S. adverse event reports is critical for the company to maintain compliance with local and international regulations. Additional responsibilities include data management activities associated with ...
S. adverse event reports is critical for the company to maintain compliance with local and international regulations. Additional responsibilities include data management activities associated with ...
S. adverse event reports is critical for the company to maintain compliance with local and international regulations. Additional responsibilities include data management activities associated with ...
S. adverse event reports is critical for the company to maintain compliance with local and international regulations. Additional responsibilities include data management activities associated with ...
Manager, Complaints and Post-Market
San Jose, CA · On-site
$141K - $177K/yr
Manage adverse event reporting activities including decision rationale and reporting documentation. * Submit adverse event reports to regulatory authorities * Manage complaint metrics and analytics ...
Manager, Complaints and Post-Market
San Jose, CA · On-site
$141K - $177K/yr
Manage adverse event reporting activities including decision rationale and reporting documentation. * Submit adverse event reports to regulatory authorities * Manage complaint metrics and analytics ...
Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory ...
Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory ...
The Lead, Complaints / Adverse Events is responsible for guiding and managing the team throughout the building and execution of quality into enterprise wide systems, tools, services and ...
The Lead, Complaints / Adverse Events is responsible for guiding and managing the team throughout the building and execution of quality into enterprise wide systems, tools, services and ...
Initiates, owns, or assists with internal audit and CAPA actions as they relate to complaint records and/or adverse event reporting * Participates in complaint record remediation planning and ...
Initiates, owns, or assists with internal audit and CAPA actions as they relate to complaint records and/or adverse event reporting * Participates in complaint record remediation planning and ...
Initiates, owns, or assists with internal audit and CAPA actions as they relate to complaint records and/or adverse event reporting * Participates in complaint record remediation planning and ...
Initiates, owns, or assists with internal audit and CAPA actions as they relate to complaint records and/or adverse event reporting * Participates in complaint record remediation planning and ...
Los Angeles, CA 90032 Duration- 4 months (Possible extension for long term) FAQ This position is for Adverse event monitoring. This person will deal with marketed products and side effects, follow up ...
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Los Angeles, CA 90032 Duration- 4 months (Possible extension for long term) FAQ This position is for Adverse event monitoring. This person will deal with marketed products and side effects, follow up ...
Clinical/Regulatory - Safety Data Coordinator
Vernon Hills, IL · On-site
$18/hr
This position is responsible for the monitoring of the global adverse event email box which includes triage of incoming initial and follow up source documents for adverse event case reports. The ...
Clinical/Regulatory - Safety Data Coordinator
Vernon Hills, IL · On-site
$18/hr
This position is responsible for the monitoring of the global adverse event email box which includes triage of incoming initial and follow up source documents for adverse event case reports. The ...
Qualifications - Provide initial medical evaluation of adverse events on company investigational and marketed products by determining the seriousness, expectedness, and therefore reportability of ...
Qualifications - Provide initial medical evaluation of adverse events on company investigational and marketed products by determining the seriousness, expectedness, and therefore reportability of ...
Regulatory Specialist, Beauty & Wellness
Marlborough, MA · On-site
$70K - $88K/yr
Determine if and potential adverse events/adverse events require a field action or CAPA to be taken on any given product line. * Coordinate the adverse event reporting process required to the ...
Regulatory Specialist, Beauty & Wellness
Marlborough, MA · On-site
$70K - $88K/yr
Determine if and potential adverse events/adverse events require a field action or CAPA to be taken on any given product line. * Coordinate the adverse event reporting process required to the ...
The Coordinator provides risk advice in a variety of areas, including consent, mandatory reporting, patient/family/visitor behavior, threat management, medication management, adverse event management ...
The Coordinator provides risk advice in a variety of areas, including consent, mandatory reporting, patient/family/visitor behavior, threat management, medication management, adverse event management ...
This role will focus on education related to selinexor's clinical profile, with an emphasis on safety, tolerability, monitoring, adverse event recognition, and supportive care considerations. The ...
This role will focus on education related to selinexor's clinical profile, with an emphasis on safety, tolerability, monitoring, adverse event recognition, and supportive care considerations. The ...
Will be responsible for several portions of the adverse event case processing workflow including but not limited to receipt, evaluation, registration, partial data entry, documentation, and reporting ...
Will be responsible for several portions of the adverse event case processing workflow including but not limited to receipt, evaluation, registration, partial data entry, documentation, and reporting ...
The Lead, Complaints / Adverse Events is responsible for guiding and managing the team throughout the building and execution of quality into enterprise wide systems, tools, services and ...
The Lead, Complaints / Adverse Events is responsible for guiding and managing the team throughout the building and execution of quality into enterprise wide systems, tools, services and ...
This role will focus on education related to selinexor's clinical profile, with an emphasis on safety, tolerability, monitoring, adverse event recognition, and supportive care considerations. The ...
This role will focus on education related to selinexor's clinical profile, with an emphasis on safety, tolerability, monitoring, adverse event recognition, and supportive care considerations. The ...
This role will focus on education related to selinexor's clinical profile, with an emphasis on safety, tolerability, monitoring, adverse event recognition, and supportive care considerations. The ...
This role will focus on education related to selinexor's clinical profile, with an emphasis on safety, tolerability, monitoring, adverse event recognition, and supportive care considerations. The ...
Regulatory Affairs Specialist
Mundelein, IL · On-site
$25 - $30/hr
Collabera is looking for an Adverse Event Specialist to review both new and historical product complaints to assess data completeness and determine MDR reportability. This individual will apply ...
Regulatory Affairs Specialist
Mundelein, IL · On-site
$25 - $30/hr
Collabera is looking for an Adverse Event Specialist to review both new and historical product complaints to assess data completeness and determine MDR reportability. This individual will apply ...
This role will focus on education related to selinexor's clinical profile, with an emphasis on safety, tolerability, monitoring, adverse event recognition, and supportive care considerations. The ...
This role will focus on education related to selinexor's clinical profile, with an emphasis on safety, tolerability, monitoring, adverse event recognition, and supportive care considerations. The ...
Medical Information Representative
$16.50 - $20.75/hr
Perform intake & generate accurate adverse event and product complaint reports in compliance with EVERSANA-MICC and client standard operating procedures. * Demonstrate knowledge of FDA's post ...
Medical Information Representative
$16.50 - $20.75/hr
Perform intake & generate accurate adverse event and product complaint reports in compliance with EVERSANA-MICC and client standard operating procedures. * Demonstrate knowledge of FDA's post ...
Adverse Event information
See salary details
$11.54 - $13.92
9% of jobs
$13.92 - $16.30
0% of jobs
$16.30 - $18.68
0% of jobs
$18.68 - $21.07
12% of jobs
$21.39 is the 25th percentile. Wages below this are outliers.
$21.07 - $23.45
25% of jobs
The median wage is $24.04 / hr.
$23.45 - $25.83
14% of jobs
$28.01 is the 75th percentile. Wages above this are outliers.
$25.83 - $28.21
15% of jobs
$28.21 - $30.59
6% of jobs
$30.59 - $32.98
0% of jobs
$32.98 - $35.36
12% of jobs
$35.36 - $37.74
5% of jobs
$11
$25
$37
How much do adverse event jobs pay per hour?
As of Jul 7, 2026, the average hourly pay for adverse event in the United States is $25.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $28.61 per hour, depending on experience, location, and employer.
What are the key skills and qualifications needed to thrive as a Pharmacovigilance (Adverse Event) Specialist, and why are they important?
To thrive as a Pharmacovigilance (Adverse Event) Specialist, you need a background in life sciences or pharmacy, knowledge of regulatory guidelines, and experience in drug safety reporting. Familiarity with safety databases such as Argus or ArisG, as well as understanding of MedDRA coding and ICH-GCP standards, is typically required. Attention to detail, analytical thinking, and strong communication skills help specialists accurately assess and report adverse events. These competencies are crucial for ensuring patient safety, regulatory compliance, and effective risk management in pharmaceutical settings.
What is the difference between Adverse Event vs Clinical Research Coordinator?
| Aspect | Adverse Event | Clinical Research Coordinator |
|---|---|---|
| Required credentials | Medical knowledge, pharmacovigilance training | Research ethics, study protocols |
| Work environment | Healthcare settings, hospitals, clinics | Research sites, hospitals, clinics |
| Employer and industry usage | Pharmaceutical companies, healthcare providers | Research institutions, hospitals |
| Common search intent | Understanding safety reporting | Managing clinical trials |
Adverse Event involves monitoring and reporting negative effects related to medical treatments, requiring medical and pharmacovigilance expertise. Clinical Research Coordinators manage and oversee clinical trials, focusing on study procedures and participant coordination. While both roles operate within healthcare and research environments, their responsibilities and required skills differ significantly.
What is an Adverse Event in the context of healthcare and clinical trials?
An Adverse Event (AE) refers to any undesirable experience or medical occurrence in a patient or clinical trial participant who has been given a pharmaceutical product or is undergoing medical treatment. These events can range from mild side effects to serious health complications and may or may not be directly caused by the treatment itself. Monitoring and reporting adverse events are essential for ensuring patient safety and for regulatory compliance in clinical research. Identifying and documenting AEs helps healthcare professionals assess risks and benefits of medications or treatments and can lead to changes in prescribing information or regulatory actions.
What are some common challenges faced by professionals working in Adverse Event reporting, and how can they be managed?
Professionals in Adverse Event reporting often encounter challenges such as tight regulatory deadlines, the need for meticulous attention to detail, and effective communication with cross-functional teams like clinical, safety, and regulatory affairs. Managing a high volume of reports while ensuring accuracy and compliance can be demanding. To address these challenges, it's important to develop strong organizational skills, stay current on regulatory changes, and build collaborative relationships within your organization. Leveraging technology and standardized processes also helps streamline reporting and ensure timely submissions.
What states have the most Adverse Event jobs? States with the most job openings for Adverse Event jobs include:
What job categories do people searching Adverse Event jobs look for? The top searched job categories for Adverse Event jobs are:
Contractor
Posted 9 days ago
Job description
Company Description
US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website http://www.ustechsolutions.com/.We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you
Job Description
Title: Safety Reconciliation Specialist
Duration: 12 Months
Location: Morristown, NJ 07962
Job Description:
The incumbent is responsible for litigation intake, including receipt of cases via email and gateway interface with from legal vendors, and related reconciliation and tracking. The incumbent is also back up to the
US PV Safety Data and Reconciliation Manager, to ensure responsible for the
receipt, prioritization, completion and archive of reconciliations with vendor partners for PSDMPs, CRSs, and AOL programs, and internal organizations in support of compliance, and as required by Pharmacovigilance Agreements with vendor partners in accordance with Company SOPs (Standard Operating Procedures) and regulatory guidelines.
The reconciliation of potential safety reports with vendor partners, and data management activities in support of litigation case handling for all incoming U.S. adverse event reports is critical for the company to maintain compliance with local and international regulations. Additional responsibilities include data management activities associated with incoming legal cases and associated medical records and US PV Triage daily workload metrics tracking activities.
Position duties & responsibilities:
• The Safety Data and Reconciliation Specialist ensures that all adverse event reports are reconciled by the local US PV organization in accordance with Pharmacovigilance Agreements and determines when additional efforts and escalation are required to ensure receipt of adverse event reports from partner vendors. Additionally, the SDRS ensures reconciliation with legal vendors for all legal medical records. This role is critical to FDA and global Health Authority compliance.
• Analyze incoming communications from vendor partners for PSDMPs,
• CRSs, and AOL programs in support of compliance, in accordance with Company SOPs (Standard Operating Procedures) and regulatory guidelines, and use critical thinking to prioritize workload of reconciliations.
• Communicate with identified external partners and programs, as well as internal functions to facilitate reconciliation processes and ensure compliance to regulatory reporting timelines regarding adverse event report forms, escalating issues as needed to management in a timely manner.
• Perform daily, weekly, and monthly reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements, as well as source documents received from other internal departments where required. Use critical thinking skills to locate and recognize adverse event reports both within the Safety Database and Document Repository, from varied and diverse formats of reconciliation listings.
• Perform archiving and tracking of reconciliations in accordance with applicable processes and procedures, using critical judgment to observe and detect any issues, and make the determination of what may result in a delay with regards to regulatory reporting timelines, notifying management as needed.
• Reconcile daily incoming volumes into Argus Intake Worklist by internal functions (Consumer Relations) and external vendor partners utilizing gateway interface to Argus Intake Worklist
• Make determination of when communication with US PV Intake Group and management is necessary to expedite potential safety cases coming in as a result of reconciliation activities.
• Analyze incoming bulk Medical Records from external Legal Vendors and other sources, in order to prepare for upload into the Document Repository and Workflow Processing system. Independently identifying any and all issues regarding Medical Records, and communicating with external Legal Vendors promptly to address them, escalating to management when necessary.
• Upload bulk Medical Records, and in consultation with Assistant
• Director, USPV MRT, triage and assign Medical Records to the appropriate users or groups for extraction.
• Monitor USPV MRT Mailbox and upload incoming Legal Complaints, or other potential legal cases into the Document Repository and Workflow Processing system.
• Identify and follow department procedures for AEs associated with product complaints.
• Track litigation metrics
Qualifications
Requirements/Preferences
Education Requirement(s):
• Requires a Bachelors of Arts or Bachelors of Science, Registered Nurse, or Pharmacist with at least 3 years of drug safety experience
Skill & Competency Requirements:
• Experience in triaging of source documents and reconciliation preferred.
• Global drug safety database knowledge is preferred along with knowledge of regulatory roles and proficiency with regulations, locally as well as globally.
• Familiarity with ARGUS Safety Database, including experience performing duplicate checks and filtering Argus reports to identify cases, is preferred.
• Must be a team player; possess excellent communication skills with a high degree of overall poise, tact and courtesy; must be detail oriented and be willing to work in a hectic paced environment with time sensitive materials.
Additional Information
All your information will be kept confidential according to EEO guidelines.
US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website http://www.ustechsolutions.com/.We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you
Job Description
Title: Safety Reconciliation Specialist
Duration: 12 Months
Location: Morristown, NJ 07962
Job Description:
The incumbent is responsible for litigation intake, including receipt of cases via email and gateway interface with from legal vendors, and related reconciliation and tracking. The incumbent is also back up to the
US PV Safety Data and Reconciliation Manager, to ensure responsible for the
receipt, prioritization, completion and archive of reconciliations with vendor partners for PSDMPs, CRSs, and AOL programs, and internal organizations in support of compliance, and as required by Pharmacovigilance Agreements with vendor partners in accordance with Company SOPs (Standard Operating Procedures) and regulatory guidelines.
The reconciliation of potential safety reports with vendor partners, and data management activities in support of litigation case handling for all incoming U.S. adverse event reports is critical for the company to maintain compliance with local and international regulations. Additional responsibilities include data management activities associated with incoming legal cases and associated medical records and US PV Triage daily workload metrics tracking activities.
Position duties & responsibilities:
• The Safety Data and Reconciliation Specialist ensures that all adverse event reports are reconciled by the local US PV organization in accordance with Pharmacovigilance Agreements and determines when additional efforts and escalation are required to ensure receipt of adverse event reports from partner vendors. Additionally, the SDRS ensures reconciliation with legal vendors for all legal medical records. This role is critical to FDA and global Health Authority compliance.
• Analyze incoming communications from vendor partners for PSDMPs,
• CRSs, and AOL programs in support of compliance, in accordance with Company SOPs (Standard Operating Procedures) and regulatory guidelines, and use critical thinking to prioritize workload of reconciliations.
• Communicate with identified external partners and programs, as well as internal functions to facilitate reconciliation processes and ensure compliance to regulatory reporting timelines regarding adverse event report forms, escalating issues as needed to management in a timely manner.
• Perform daily, weekly, and monthly reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements, as well as source documents received from other internal departments where required. Use critical thinking skills to locate and recognize adverse event reports both within the Safety Database and Document Repository, from varied and diverse formats of reconciliation listings.
• Perform archiving and tracking of reconciliations in accordance with applicable processes and procedures, using critical judgment to observe and detect any issues, and make the determination of what may result in a delay with regards to regulatory reporting timelines, notifying management as needed.
• Reconcile daily incoming volumes into Argus Intake Worklist by internal functions (Consumer Relations) and external vendor partners utilizing gateway interface to Argus Intake Worklist
• Make determination of when communication with US PV Intake Group and management is necessary to expedite potential safety cases coming in as a result of reconciliation activities.
• Analyze incoming bulk Medical Records from external Legal Vendors and other sources, in order to prepare for upload into the Document Repository and Workflow Processing system. Independently identifying any and all issues regarding Medical Records, and communicating with external Legal Vendors promptly to address them, escalating to management when necessary.
• Upload bulk Medical Records, and in consultation with Assistant
• Director, USPV MRT, triage and assign Medical Records to the appropriate users or groups for extraction.
• Monitor USPV MRT Mailbox and upload incoming Legal Complaints, or other potential legal cases into the Document Repository and Workflow Processing system.
• Identify and follow department procedures for AEs associated with product complaints.
• Track litigation metrics
Qualifications
Requirements/Preferences
Education Requirement(s):
• Requires a Bachelors of Arts or Bachelors of Science, Registered Nurse, or Pharmacist with at least 3 years of drug safety experience
Skill & Competency Requirements:
• Experience in triaging of source documents and reconciliation preferred.
• Global drug safety database knowledge is preferred along with knowledge of regulatory roles and proficiency with regulations, locally as well as globally.
• Familiarity with ARGUS Safety Database, including experience performing duplicate checks and filtering Argus reports to identify cases, is preferred.
• Must be a team player; possess excellent communication skills with a high degree of overall poise, tact and courtesy; must be detail oriented and be willing to work in a hectic paced environment with time sensitive materials.
Additional Information
All your information will be kept confidential according to EEO guidelines.
About US Tech Solutions
Sourced by ZipRecruiter
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.
Industry
It services
Company size
1,001 - 5,000 Employees
Headquarters location
Jersey City, NJ, US
Year founded
2000