Global Pharmacovigilance Operations Lead

Precigen; Germantown (MD); On-site; USD 120,000 - 170,000; Full time

Job summary

Precigen is seeking a Manager, Drug Safety Operations to oversee day-to-day pharmacovigilance activities and external PV vendors. You will ensure compliance with US and international regulations, track KPIs and SLAs, and support safety reporting requirements in a cross-functional team.

You will coordinate vendor selection, negotiate PV contracts, and help maintain SOPs and PV processes, including audits and inspections readiness.

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or related field (advanced degree a plus).
• 3–5 years in pharmacovigilance or drug safety, including vendor/outside oversight.
• Experience supporting regulatory inspections.
• Experience with safety databases (Argus) and ICSR processing.
• Familiarity with PVAs, audit management, and risk-based oversight.
• Strong knowledge of US and international pharmacovigilance regulatory requirements.

Responsibilities

• Manage day-to-day relationships with PV vendors and be the primary operational contact.
• Coordinate vendor selection activities (RFPs, bid defenses, due diligence).
• Support negotiation and maintenance of PV contracts and SOWs.
• Track KPIs and SLAs; monitor regulatory compliance and escalate risks.
• Oversee vendor AE, SAE, SUSAR activities and data migration.
• Develop and maintain SOPs, forms, templates, and guidelines.

Skills

Vendor management

Contract management

Budget management

Cross-functional collaboration

Regulatory awareness

Stakeholder management

Education

Bachelor's degree in life sciences, nursing, pharmacy, or related field

Tools

Argus

DSUR preparation

MedDRA

Job description

Precigen is seeking a Manager, Drug Safety Operations to oversee day-to-day pharmacovigilance activities and external PV vendors. You will ensure compliance with US and international regulations, track KPIs and SLAs, and support safety reporting requirements in a cross-functional team.

You will coordinate vendor selection, negotiate PV contracts, and help maintain SOPs and PV processes, including audits and inspections readiness.