Manager, Drug Safety Operations

Precigen is seeking a Manager, Drug Safety Operations reporting to our Senior Medical Director, Development and Pharmacovigilance. This role is responsible for supporting Precigen’s day-to-day pharmacovigilance activities through effective oversight of external PV service providers. The individual will serve as the point of contact for PV vendors, helping to ensure that safety operations are conducted in compliance with applicable regulations, contractual obligations, and company procedures. Key responsibilities include coordinating and monitoring vendor case processing activities, tracking the quality and performance of drug safety database operations, supporting safety reporting requirements, and escalating operational or compliance issues to PV leadership. The role works cross-functionally to support the implementation of established risk management and PV processes for Precigen’s products.

DUTIES AND RESPONSIBILITIES:

• Manage day-to-day relationships with PV vendors and serve as the primary operational contact
• Coordinate vendor selection activities, including RFPs, bid defenses, and operational due diligence, in partnership with PV leadership and relevant internal stakeholders.
• Support negotiation and maintenance of contracts, SOWs, change orders, and Pharmacovigilance Agreements (PVAs/SDEAs)
• Track and report KPIs and SLAs (e.g., case timeliness, quality scores, backlog, ICSR compliance rates)
• Monitor vendor adherence to applicable US and international PV regulations, adverse event reporting requirements. Escalate identified compliance risks to PV leadership.
• Manage the operational execution of vendor-performed AE, SAE, and SUSAR activities. Escalate significant case or compliance issues to PV and medical safety leadership.
• Contribute to the development and maintenance of Standard Operating Procedures (SOP), forms, templates, and guidelines to ensure compliance.
• Facilitate regular governance meetings and escalate issues, risks, and corrective actions.
• Oversee vendor budgets, invoicing, forecasting, and out-of-scope work
• Partner with Quality Assurance on vendor audits, CAPAs, and inspection readiness
• Monitor vendor activities comply with GVP, FDA, EMA, ICH, and local regulations and escalate identified gaps to PV leadership and QA.
• Support onboarding, training, and transitions of vendors, including offboarding and data migration
• Contribute to SOPs, work instructions, and vendor oversight plans
• Support regulatory inspections and audits as a the operational subject matter resource on vendor oversight
• Coordinate with corporate compliance and PV leadership to administer approved PV training throughout Precigen.
• Provide operational support for signal management and benefit-risk activities led by leadership, including coordination of vendor data and deliverables (e.g., Periodic Adverse Drug Event (PADER), Drug Safety Update Reports (DSUR), etc.).
• Other duties as assigned.