Global Drug Safety & Pharmacovigilance Operations * Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products * In partnership with Clinical Research ...
Global Drug Safety & Pharmacovigilance Operations * Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products * In partnership with Clinical Research ...
The core mission of the Verastem Safety & Pharmacovigilance group is to ensure patient safety for ... Reporting to the Vice President, PV Operations and Compliance, Senior Pharmacovigilance Operations ...
The core mission of the Verastem Safety & Pharmacovigilance group is to ensure patient safety for ... Reporting to the Vice President, PV Operations and Compliance, Senior Pharmacovigilance Operations ...
Build and maintain fitforpurpose pharmacovigilance operations suitable for a clinicalstage biotech. * Manage PV vendors and CROs supporting case processing, literature review, and safety reporting.
Build and maintain fitforpurpose pharmacovigilance operations suitable for a clinicalstage biotech. * Manage PV vendors and CROs supporting case processing, literature review, and safety reporting.
This executive will ensure scientific excellence, regulatory alignment, and operational rigor. The ... Pharmacovigilance Operations & Compliance * Oversee global PV systems and processes, including case ...
This executive will ensure scientific excellence, regulatory alignment, and operational rigor. The ... Pharmacovigilance Operations & Compliance * Oversee global PV systems and processes, including case ...
Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology)
Boston, MA · On-site
$200K - $250K/yr
Build and maintain fit-for-purpose pharmacovigilance operations suitable for a clinical-stage biotech. * Manage PV vendors and CROs supporting case processing, literature review, and safety reporting.
Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology)
Boston, MA · On-site
$200K - $250K/yr
Build and maintain fit-for-purpose pharmacovigilance operations suitable for a clinical-stage biotech. * Manage PV vendors and CROs supporting case processing, literature review, and safety reporting.
Minimum of 3 years Patient Safety & Pharmacovigilance experience in a global environment * Experience in post marketing safety operations preferred * Working knowledge of FDA, EU and ICH guidelines ...
Minimum of 3 years Patient Safety & Pharmacovigilance experience in a global environment * Experience in post marketing safety operations preferred * Working knowledge of FDA, EU and ICH guidelines ...
Strong global knowledge and understanding of international PV regulations applicable to the conduct of clinical trials and pharmacovigilance operations * Metrics & Continuous Improvement * Keep up to ...
Strong global knowledge and understanding of international PV regulations applicable to the conduct of clinical trials and pharmacovigilance operations * Metrics & Continuous Improvement * Keep up to ...
Senior PV Operations Specialist
Boston, MA · On-site
$116K - $143K/yr
The core mission of the Verastem Safety & Pharmacovigilance group is to ensure patient safety for ... Reporting to the Vice President, PV Operations and Compliance, Senior Pharmacovigilance Operations ...
Senior PV Operations Specialist
Boston, MA · On-site
$116K - $143K/yr
The core mission of the Verastem Safety & Pharmacovigilance group is to ensure patient safety for ... Reporting to the Vice President, PV Operations and Compliance, Senior Pharmacovigilance Operations ...
Senior Specialist I, Postmarketing Patient Safety and Pharmacovigilance Operations
Redwood City, CA · On-site
$103K - $137K/yr
Minimum of 3 years Patient Safety & Pharmacovigilance experience in a global environment * Experience in post marketing safety operations preferred * Working knowledge of FDA, EU and ICH guidelines ...
Senior Specialist I, Postmarketing Patient Safety and Pharmacovigilance Operations
Redwood City, CA · On-site
$103K - $137K/yr
Minimum of 3 years Patient Safety & Pharmacovigilance experience in a global environment * Experience in post marketing safety operations preferred * Working knowledge of FDA, EU and ICH guidelines ...
In depth understanding of clinical research and pharmacovigilance operations and regulations-in particular an excellent knowledge of ICH GCP, GVP as well as FDA, EU and ROW regulations 5 + years of ...
In depth understanding of clinical research and pharmacovigilance operations and regulations-in particular an excellent knowledge of ICH GCP, GVP as well as FDA, EU and ROW regulations 5 + years of ...
Who You Are This is an exciting opportunity for a highly motivated Pharmacology Operations Research Associate II to contribute to drug discovery activities for the development of novel small molecule ...
Who You Are This is an exciting opportunity for a highly motivated Pharmacology Operations Research Associate II to contribute to drug discovery activities for the development of novel small molecule ...
Pharmacology Operations Research Associate (Contract)
South San Francisco, CA · On-site
$42 - $46/hr
Who You Are This is an exciting opportunity for a highly motivated Pharmacology Operations Research Associate II to contribute to drug discovery activities for the development of novel small molecule ...
Pharmacology Operations Research Associate (Contract)
South San Francisco, CA · On-site
$42 - $46/hr
Who You Are This is an exciting opportunity for a highly motivated Pharmacology Operations Research Associate II to contribute to drug discovery activities for the development of novel small molecule ...
Pharmacology Operations Research Associate (Contract)
South San Francisco, CA · On-site
$42 - $46/hr
Who You Are This is an exciting opportunity for a highly motivated Pharmacology Operations Research Associate II to contribute to drug discovery activities for the development of novel small molecule ...
New
Pharmacology Operations Research Associate (Contract)
South San Francisco, CA · On-site
$42 - $46/hr
Who You Are This is an exciting opportunity for a highly motivated Pharmacology Operations Research Associate II to contribute to drug discovery activities for the development of novel small molecule ...
New
Safety Operations Physician
Redwood City, CA · On-site
Provide overall case assessment and pharmacovigilance comment on ICSRs as needed. Leadership ... and Safety Operations partners as needed. * Help shape a consistent, high-quality approach to ...
Safety Operations Physician
Redwood City, CA · On-site
Provide overall case assessment and pharmacovigilance comment on ICSRs as needed. Leadership ... and Safety Operations partners as needed. * Help shape a consistent, high-quality approach to ...
The position contributes to signal detection activities, literature review, and operational pharmacovigilance processes, while collaborating with cross-functional teams and providing support to ...
The position contributes to signal detection activities, literature review, and operational pharmacovigilance processes, while collaborating with cross-functional teams and providing support to ...
Safety Operations Physician
Redwood City, CA · On-site
Provide overall case assessment and pharmacovigilance comment on ICSRs as needed. Leadership ... and Safety Operations partners as needed. * Help shape a consistent, high-quality approach to ...
Safety Operations Physician
Redwood City, CA · On-site
Provide overall case assessment and pharmacovigilance comment on ICSRs as needed. Leadership ... and Safety Operations partners as needed. * Help shape a consistent, high-quality approach to ...
Associate Medical Director
San Diego, CA · On-site
$210K - $250K/yr
The position contributes to signal detection activities, literature review, and operational pharmacovigilance processes, while collaborating with cross-functional teams and providing support to ...
Associate Medical Director
San Diego, CA · On-site
$210K - $250K/yr
The position contributes to signal detection activities, literature review, and operational pharmacovigilance processes, while collaborating with cross-functional teams and providing support to ...
Responsible for ensuring recruitment, development of top safety talent and retention of high performing associates to maintain stable pharmacovigilance operations. * Ensure regular performance ...
Responsible for ensuring recruitment, development of top safety talent and retention of high performing associates to maintain stable pharmacovigilance operations. * Ensure regular performance ...
Participates in the development of Global Patient Safety Operations operational objectives ... Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety ...
Participates in the development of Global Patient Safety Operations operational objectives ... Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety ...
Participates in the development of Global Patient Safety Operations operational objectives ... Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety ...
Participates in the development of Global Patient Safety Operations operational objectives ... Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety ...
Pharmacovigilance Operations information
See salary details
$12.26 - $18.95
7% of jobs
$18.95 - $25.63
4% of jobs
$25.63 - $32.32
3% of jobs
$38.25 is the 25th percentile. Wages below this are outliers.
$32.32 - $39.01
12% of jobs
The median wage is $44.20 / hr.
$39.01 - $45.69
31% of jobs
$45.69 - $52.38
15% of jobs
$54.36 is the 75th percentile. Wages above this are outliers.
$52.38 - $59.07
12% of jobs
$59.07 - $65.76
0% of jobs
$65.76 - $72.44
9% of jobs
$72.44 - $79.13
5% of jobs
$79.13 - $85.82
2% of jobs
$12
$49
$85
How much do pharmacovigilance operations jobs pay per hour?
What is the difference between Pharmacovigilance Operations vs Pharmacovigilance Associate?
| Aspect | Pharmacovigilance Operations | Pharmacovigilance Associate |
|---|---|---|
| Responsibilities | Oversees safety data collection, processing, and reporting; manages PV systems and compliance | Supports data entry, case processing, and documentation under supervision |
| Required Credentials | Bachelor's degree in life sciences; relevant PV certifications often preferred | Bachelor's degree; entry-level PV training or certifications beneficial |
| Work Environment | Typically in pharmaceutical or biotech companies, regulatory agencies |
Pharmacovigilance Operations involves managing safety data and ensuring compliance, often requiring more experience and specialized knowledge. Pharmacovigilance Associates support data entry and case processing, serving as entry-level roles. Both roles are essential in the PV industry, with Operations focusing on oversight and Associates on support tasks.
Will AI replace pharmacovigilance jobs?
What are pharmacovigilance operations?
What is the highest salary in pharmacovigilance?
What is Pharmacovigilance Operations?
Is pharmacovigilance a good career path?
What are the key skills and qualifications needed to thrive in Pharmacovigilance Operations, and why are they important?
What are some common challenges faced in a Pharmacovigilance Operations role, and how can they be managed?

Full-time
Medical, Dental, Vision, Life, Retirement
Posted 24 days ago
Job description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Open to filling at either Senior Manager or Director level
The Experienced Senior Manager of Pharmacovigilance will be responsible for the execution of global pharmacovigilance activities supporting late-stage clinical development and preparation for first commercial launch of small-molecule oncology products in lung and prostate cancer. This role will ensure compliance with global safety regulations and will work closely with cross-functional partners to ensure individual case safety report (ICSR) processing, Health Authority submissions, and post-marketing safety readiness.
This is a hands-on role well suited for a biotech environment requiring both operational excellence and cross-functional collaboration.
Job Description
Global Drug Safety & Pharmacovigilance Operations
- Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products
- In partnership with Clinical Research Organizations (CROs), oversee intake, assessment, processing, medical review, and reporting of ICSRs from clinical trials, adhering to established processes and timelines
- Ensure timely submission of expedited and periodic safety reports to Regulatory Authorities, IRBs/ECs, clinical investigators, and business partners
- Support preparation and submission of DSURs, periodic safety reports/listings, and updates to Investigator Brochures (IBs)
- Develop, maintain and execute Safety Management Plans for clinical studies
Clinical Development & Regulatory Affairs Support
- Contribute to safety sections of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and IND/NDA/MAA/CTAs (as applicable)
- Review clinical trial safety data and assist with data cleaning for ongoing studies
- Participate in periodic safety reviews, signal detection and risk evaluation activities
- Maintain Reference Safety Information for the client's products and co-administered IMPs
- Support launch readiness activities including development of post-marketing pharmacovigilance processes, development and maintenance of Risk Management Plans (RMPs) and REMS (as applicable)
- Assist with preparation for regulatory inspections and audits
Cross-Functional Collaboration
- Participate in internal Safety Management Teams and governance meetings
- Partner with Clinical, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams
- Support safety training for internal stakeholders and investigators
Vendor & Compliance Oversight
- Support oversight of pharmacovigilance vendors and service providers
- Ensure Safety Data Exchange Agreements (SDEAs) are implemented and maintained
- Assist in development and maintenance of SOPs and training materials
Required Qualifications
- Bachelor's degree in life sciences, pharmacy, nursing, or related discipline with demonstrated knowledge of medical terminology
- 12 years' pharmacovigilance experience with Bachelor's degree -or- 8 years' experience and Master's degree -or- 5 years' experience and PhD-including clinical trial and/or post-marketing experience
- Experience with small-molecule oncology products
- Working knowledge of global pharmacovigilance regulations, including FDA, EMA, Health Canada, and Asian Health Authorities (e.g., Japan PMDA, South Korea MFDS)
- Experience using validated safety databases (e.g., Argus, ARISg) and clinical trial databases
Preferred Qualifications
- Oncology experience in lung and/or prostate cancer
- Experience in biotech/ small pharmaceutical company or CRO environments
- Experience supporting NDA/MAA submissions and commercial launch
- Familiarity with REMS, RMPs, and post-marketing commitments
Skills and Attributes
- Strong strategic thinking combined with a hands-on, execution-focused mindset
- Proven ability to collaborate and lead in a cross-functional, matrixed organization
- Excellent written and verbal communication skills, with the ability to convey complex data clearly
- Highly organized, adaptable, and comfortable working in a fast-paced, evolving environment
- Mission-driven, patient-focused, and committed to scientific integrity
- To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply