Manager, Pharmacovigilance Operations (Contractor)

Manager, Pharmacovigilance Operations (Contractor) at Everforth Apex

Location: Waltham, MA

Our client, a clinical-stage biopharmaceutical organization is seeking a Consultant Manager, Pharmacovigilance Operations to support global safety case management, vendor oversight, and PV operational activities across clinical and commercial programs. This role partners closely with internal teams and external vendors to ensure high-quality safety reporting and regulatory compliance.

Key Responsibilities

• Oversee PV case management, safety reporting, and compliance monitoring for investigational and commercial products
• Lead day-to-day PV vendor oversight, performance evaluation, and quality monitoring
• Support safety operations for assigned clinical studies, including SAE reconciliation
• Contribute to Safety Data Exchange Agreements and PV-related partner/vendor contracts
• Develop safety-related study documents (Safety Management Plans, reporting forms, reconciliation plans)
• Support regulatory inspections, audits, and responses to health authority safety requests
• Maintain PV system policies, SOPs, and ensure alignment with evolving global regulations
• Collaborate cross-functionally with Medical Affairs, Commercial, and other teams on safety processes

Qualifications

• Bachelor’s or advanced degree in life sciences or a healthcare field
• 5–7+ years of pharmacovigilance experience
• Proficiency with safety databases (ARGUS, ARISg), EDC systems, and document management tools
• Strong knowledge of GCP, ICH, FDA/EMA regulations, MedDRA, and WHO Drug
• Experience managing PV vendors and ICSR submissions is required
• Highly organized, detail-oriented, and able to manage multiple priorities
• Strong communication, problem-solving skills, and a proactive mindset
• Experience with safety database configuration/validation is a plus

About Stratacuity:

• Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information.

• PROVEN SCIENTIFIC PLACEMENT

• Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

• Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards.

Benefits

• Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Everforth Apex team member can provide.
• Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, protected veteran status, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.