Contractor, Manager, PV Operations

# Contractor, Manager, PV Operations Apply
** Job#: 3051512
***
* Job Description:

** Manager, Pharmacovigilance Operations (Contractor)

Location:

Waltham, MAOur 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. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals.

We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENTTMStratacuity 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.

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* 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, including Clearly Rateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
** Everforth Apex uses a virtual recruiter as part of the application…