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Pharmacovigilance Operations Jobs (NOW HIRING)

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Sr. Manager of Pharmacovigilance

Blue Bell, PA · On-site

Global Drug Safety & Pharmacovigilance Operations * Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products * In partnership with Clinical Research ...

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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 14, 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.
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Pharmacovigilance Operations jobs near you
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.
Director, Pharmacovigilance

Director, Pharmacovigilance

Umoja Biopharma

Seattle, WA

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 13 days ago

Job description

Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

Umoja Biopharma – Your Body. Your Hope. Your Cure.

POSITION SUMMARY:

The Director of Pharmacovigilance (PV) will play a critical role in executing Umoja Biopharma's global safety strategy across clinical-stage programs. This individual will be responsible for day-to-day pharmacovigilance operations, ensuring high-quality safety data management, regulatory compliance, and effective signal detection.

Working cross-functionally with Clinical Development, Regulatory, and external partners, the Director will help build and optimize scalable PV processes to support Umoja's advancing pipeline, with an emphasis on operational excellence and inspection readiness.

This role will operate as an Individual Contributor and manage PV relationships with vendors and CROs to start. This person may be responsible for building the Pharmacovigilance team and organization in Umoja in the near future.

This position will ideally be based out of our Seattle, WA office and work onsite at least 2 days/week. This position may have the ability to be remote in the US based on candidate experience.

CORE ACCOUNTABILITIES:

Pharmacovigilance Operations

  • Oversee case processing activities, including intake, triage, medical review support, and expedited reporting
  • Ensure compliance with global safety reporting requirements (FDA, EMA, ICH guidelines)
  • Manage relationships with PV vendors/CROs, ensuring service quality, timeliness, and data integrity
  • Support maintenance of safety databases and related systems (e.g., Argus, ArisGlobal)
  • Coordinate with Clinical Development to drive internal cross-functional pharmacovigilance activities

Aggregate Reporting & Regulatory Support

  • Lead or contribute to preparation of DSURs, PSURs/PBRERs, and IND safety reports
  • Support safety sections of regulatory submissions and responses to health authority queries
  • Contribute to development and maintenance of SOPs and Pharmacovigilance System Master File (PSMF)

Signal Detection & Risk Management

  • Support signal detection activities, including data review, trend analysis, and documentation
  • Participate in safety review meetings and cross-functional risk discussions
  • Assist in development and implementation of Risk Management Plans (RMPs)

Cross-Functional Collaboration

  • Partner with Clinical Development on protocol safety design, adverse event monitoring, and investigator communications
  • Collaborate with Regulatory Affairs to ensure alignment on safety reporting strategy
  • Support Medical Affairs in communicating safety information as needed

Inspection Readiness & Quality

  • Ensure PV processes are audit- and inspection-ready
  • Participate in internal audits, vendor audits, and regulatory inspections
  • Drive continuous improvement initiatives across PV operations

The successful candidate will have:

Education & Experience

  • Advanced degree (PharmD, PhD, MD, or MS) or health-related degree/certification (PA, RN, NP)) with at least 10 years of pharmacovigilance experience in biotech or pharmaceutical industry is required
  • Experience supporting clinical-stage programs and working with outsourced PV models
  • Exposure to regulatory submissions and inspections preferred

Technical Expertise

  • Strong working knowledge of global pharmacovigilance regulations (FDA, EMA, ICH)
  • Experience with safety databases and case processing workflows
  • Familiarity with aggregate reporting and signal detection processes
  • Experience in oncology, cell therapy, or gene therapy preferred

Leadership & Operating Style

  • Strong execution focus with attention to detail and quality
  • Ability to manage external partners and influence cross-functional teams
  • Comfortable operating in a fast-paced, evolving biotech environment
  • Proactive problem-solver with sound judgment

Physical Requirements:

  • The ideal candidate will be able to work onsite based out of our Seattle, WA office at least 2 days/week. There may be the ability to work remotely within the US and travel to Seattle, WA at least 5 days/month.
  • Ability to travel as needed
  • Ability to sit for prolonged periods of time

Salary Range: $204,000 - $305,000

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.