$150K - $250K/yr
... knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety ... Serve as a leading medical safety resource for the development and review of clinical trial ...
Quick apply
$150K - $250K/yr
... knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety ... Serve as a leading medical safety resource for the development and review of clinical trial ...
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We ... to define emerging drug safety profiles of all products and drive patient risk management.
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We ... to define emerging drug safety profiles of all products and drive patient risk management.
The Drug Safety Physician in Drug Safety & Pharmacovigilance department will serve as a subject ... Experience integrating biomarker data into safety monitoring and risk management strategies
The Drug Safety Physician in Drug Safety & Pharmacovigilance department will serve as a subject ... Experience integrating biomarker data into safety monitoring and risk management strategies
The Drug Safety Physician in Drug Safety & Pharmacovigilance department will serve as a subject ... Experience integrating biomarker data into safety monitoring and risk management strategies
Quick apply
The Drug Safety Physician in Drug Safety & Pharmacovigilance department will serve as a subject ... Experience integrating biomarker data into safety monitoring and risk management strategies
The Drug Safety Physician in Drug Safety & Pharmacovigilance department will serve as a subject ... Experience integrating biomarker data into safety monitoring and risk management strategies
The Drug Safety Physician in Drug Safety & Pharmacovigilance department will serve as a subject ... Experience integrating biomarker data into safety monitoring and risk management strategies
Princeton, NJ · On-site
Serve as a leading medical safety resource for the development and review of clinical trial ... Serve as a subject matter expert for vendors that provide drug safety and pharmacovigilance ...
Quick apply
Princeton, NJ · On-site
Serve as a leading medical safety resource for the development and review of clinical trial ... Serve as a subject matter expert for vendors that provide drug safety and pharmacovigilance ...
Princeton, NJ · On-site
$150K - $250K/yr
Serve as a leading medical safety resource for the development and review of clinical trial ... Serve as a subject matter expert for vendors that provide drug safety and pharmacovigilance ...
Princeton, NJ · On-site
$150K - $250K/yr
Serve as a leading medical safety resource for the development and review of clinical trial ... Serve as a subject matter expert for vendors that provide drug safety and pharmacovigilance ...
Safety database data entry * Perform quality control of safety cases * Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes.
Safety database data entry * Perform quality control of safety cases * Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes.
Reviews and maintains scientific response content, knowledge resources, and documentation records ... Drug Safety Associate - Bilingual - French - 12-Month Contract role. Affiliated Companies:
Reviews and maintains scientific response content, knowledge resources, and documentation records ... Drug Safety Associate - Bilingual - French - 12-Month Contract role. Affiliated Companies:
Safety database data entry * Perform quality control of safety cases * Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes.
Safety database data entry * Perform quality control of safety cases * Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes.
Safety Specialist/Sr. Triage Associate Job ID: 21435-1 Location: Pennington, New Jersey- 08534 ... Serves as a resource to identify CLIENT products and designated co-marketers. Incorporates medical ...
Safety Specialist/Sr. Triage Associate Job ID: 21435-1 Location: Pennington, New Jersey- 08534 ... Serves as a resource to identify CLIENT products and designated co-marketers. Incorporates medical ...
Horsham, PA · On-site
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... Licensed Practical Nurse without Bachelors degree but with knowledge of Drug Safety usually ...
Horsham, PA · On-site
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... Licensed Practical Nurse without Bachelors degree but with knowledge of Drug Safety usually ...
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Drug Safety, Drug Development, Clinical Trials, Regulatory Compliance, Product Launch, Quality ...
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Drug Safety, Drug Development, Clinical Trials, Regulatory Compliance, Product Launch, Quality ...
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Previous experience in drug safety or clinical research required, ideally 2-4 years * Experienced ...
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Previous experience in drug safety or clinical research required, ideally 2-4 years * Experienced ...
Raleigh, NC · On-site
$120 - $180/hr
Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies. * Writes procedural documents including Standard ...
Raleigh, NC · On-site
$120 - $180/hr
Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies. * Writes procedural documents including Standard ...
Phoenix, AZ · On-site
$120 - $180/hr
Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies. * Writes procedural documents including Standard ...
Phoenix, AZ · On-site
$120 - $180/hr
Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies. * Writes procedural documents including Standard ...
Austin, TX · On-site
$120 - $180/hr
Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies. * Writes procedural documents including Standard ...
Austin, TX · On-site
$120 - $180/hr
Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies. * Writes procedural documents including Standard ...
Canton, MI · On-site
$120 - $180/hr
Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies. * Writes procedural documents including Standard ...
Canton, MI · On-site
$120 - $180/hr
Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies. * Writes procedural documents including Standard ...
Chicago, IL · On-site
$120 - $180/hr
Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies. * Writes procedural documents including Standard ...
Chicago, IL · On-site
$120 - $180/hr
Provides technical assistance and support to Drug Safety Associate team with electronic submissions of serious adverse advents to European agencies. * Writes procedural documents including Standard ...
Piscataway, NJ · On-site
Global Pharma Tek offers services like Drug Discovery, Clinical Trials, Drug Delivery, Regulatory ... integration and enterprise architecture development, enterprise resource planning and custom ...
Piscataway, NJ · On-site
Global Pharma Tek offers services like Drug Discovery, Clinical Trials, Drug Delivery, Regulatory ... integration and enterprise architecture development, enterprise resource planning and custom ...
What makes Integrated Resources an attractive place to work?
$150K - $250K/yr
Full-time
Re-posted 11 days ago
This individual is to lead medical assessment and interpretation of safety data from multiple sources, including clinical trials, and literature reports. The individual will be closely collaborating with cross functional teams in supporting all clinical development programs, regulatory filling, and global safety related activities. This individual will also support the clinical R&D team in the oversight of PV service vendors and partners and will need to maintain medical knowledge, as well as current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.
This role requires a full-time onsite presence at our Princeton, NJ location.
Responsibilities
Provide medical safety input and participate in safety surveillance activities (e.g., identification of safety signals and ensure timely assessment and communication of confirmed safety signals).
Provide input in the generation of aggregate safety reports (e.g., DSURs, PADER, PBRER).
Serve as a leading medical safety resource for the development and review of clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs) and Reference Safety Information (RSI).
Collaborate with Medical Monitors and Clinical Research Scientists and vendor clinical staff as needed for ongoing clinical trials.
Provide medical safety input in the development and/or updates of Risk Management Plans and the maintenance of these documents.
Provide support and input to the development of Standard Operating Procedures, Working Instructions, and other guidance documents.
Serve as a subject matter expert for vendors that provide drug safety and pharmacovigilance services.
Work closely with other Product Safety Leads to respond to and resolve safety questions from health authorities as well as regulatory agency’s audits and inspections.
Qualifications
5+ years’ experience in Drug Safety/Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency.
Medical Degree (MD) from a recognized medical school with medical practice experience. Oncology / Hematology experience strongly preferred.
Strong working knowledge of US and EU drug safety and pharmacovigilance regulations, CIOMS and ICH guidelines.
Proven experience in medical safety assessments, safety surveillance and risk management activities.
Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER)
Experience in preparation of responses to regulatory authorities; experience with regulatory filing and related activities preferred.
Compensation and Benefits:
The expected base salary range for this position is $150,000 - $250,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
Sourced by ZipRecruiter
Recruiting and staffing services
51 - 200 Employees
Bellevue, WA, US
2014
