Manager, Pharmacovigilance Operations
Stratacuity: Proven Scientific Placement, Waltham, Massachusetts, United States, 02254
Manager, Pharmacovigilance Operations (Contractor)
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
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
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
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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
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
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
#J-18808-Ljbffr