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Pharmacovigilance Operations Jobs (NOW HIRING)

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 ...

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 ...

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 ...

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Pharmacovigilance Operations information

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$12

$49

$85

How much do pharmacovigilance operations jobs pay per hour?

As of Jul 19, 2026, the average hourly pay for pharmacovigilance operations in the United States is $49.14, according to ZipRecruiter salary data. Most workers in this role earn between $38.46 and $55.53 per hour, depending on experience, location, and employer.

What is the difference between Pharmacovigilance Operations vs Pharmacovigilance Associate?

AspectPharmacovigilance OperationsPharmacovigilance Associate
ResponsibilitiesOversees safety data collection, processing, and reporting; manages PV systems and complianceSupports data entry, case processing, and documentation under supervision
Required CredentialsBachelor's degree in life sciences; relevant PV certifications often preferredBachelor's degree; entry-level PV training or certifications beneficial
Work EnvironmentTypically 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?

AI is increasingly used in pharmacovigilance operations to assist with data analysis, signal detection, and case processing, but it is unlikely to fully replace pharmacovigilance professionals. Human expertise remains essential for interpreting complex safety data, making clinical judgments, and ensuring regulatory compliance. Pharmacovigilance jobs will evolve to include oversight of AI tools and data management skills.

What are pharmacovigilance operations?

Pharmacovigilance operations involve monitoring, detecting, assessing, and reporting adverse drug reactions and safety issues related to pharmaceutical products. Professionals in this field use tools like safety databases and follow regulatory guidelines to ensure medication safety throughout a product's lifecycle.

What is the highest salary in pharmacovigilance?

The highest salaries in pharmacovigilance operations can reach over $150,000 annually for senior roles such as PV managers or directors with extensive experience and certifications. Factors influencing top salaries include industry, location, company size, and specialized skills like signal detection and regulatory knowledge.

What is Pharmacovigilance Operations?

Pharmacovigilance Operations refers to the processes and activities involved in monitoring, detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It ensures the safety of pharmaceutical products by collecting and analyzing data on side effects, coordinating case processing, reporting to regulatory authorities, and implementing risk management strategies. Professionals in pharmacovigilance operations play a key role in compliance with regulatory requirements and in protecting public health.

Is pharmacovigilance a good career path?

Pharmacovigilance is a growing field that involves monitoring the safety of medicines and requires skills in data analysis, medical knowledge, and regulatory compliance. It offers opportunities in pharmaceutical companies, CROs, and healthcare organizations, often with roles that require attention to detail and knowledge of safety reporting systems. The career can be stable and rewarding for those interested in drug safety and regulatory affairs.

What are the key skills and qualifications needed to thrive in Pharmacovigilance Operations, and why are they important?

To thrive in Pharmacovigilance Operations, you need a background in life sciences or pharmacy, strong analytical abilities, and a solid understanding of drug safety regulations. Familiarity with safety databases like Argus or ArisG, and knowledge of regulatory systems such as FDA and EMA guidelines, are typically required. Attention to detail, effective communication, and the ability to work well under pressure are crucial soft skills for this role. These competencies ensure accurate adverse event reporting, regulatory compliance, and the protection of patient safety.

What are some common challenges faced in a Pharmacovigilance Operations role, and how can they be managed?

Pharmacovigilance Operations professionals often encounter challenges such as handling large volumes of adverse event reports, ensuring data quality, and meeting tight regulatory deadlines. Effective management typically involves strong organizational skills, attention to detail, and the use of specialized pharmacovigilance databases and tools. Collaborating closely with cross-functional teams—such as regulatory affairs and clinical teams—helps ensure accurate case processing and timely submissions. Continuous training and staying updated with evolving global regulations are also key to successfully navigating these challenges.
More about Pharmacovigilance Operations jobs
What cities are hiring for Pharmacovigilance Operations jobs? Cities with the most Pharmacovigilance Operations job openings:
What states have the most Pharmacovigilance Operations jobs? States with the most job openings for Pharmacovigilance Operations jobs include:
Infographic showing various Pharmacovigilance Operations job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 86% Full Time, 11% Part Time, 1% Temporary, and 1% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $102,217 per year, or $49.1 per hour.
Sr. Manager of Pharmacovigilance

Sr. Manager of Pharmacovigilance

ICON

Blue Bell, PA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 24 days ago


Job description

Experienced Senior Manager of Pharmacovigilance - Oncology - Home Based (US)
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