Drug Safety Operations Lead

Precigen; Germantown (MD); On-site; USD 120,000 - 135,000; Full time

Job summary

Precigen is a commercial-stage biopharmaceutical company focused on precision medicines. We seek a Manager, Drug Safety Operations to oversee day-to-day pharmacovigilance activities, vendor performance, and compliance with GVP, FDA, EMA and ICH guidelines.

You will partner with PV leadership to ensure safe, compliant operations and successful regulatory interactions. The role requires coordinating vendor activities, managing budgets, and helping implement risk management processes across

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
• 3–5 years in pharmacovigilance or drug safety, including vendor oversight.
• Experience supporting regulatory inspections.
• Working knowledge of global PV regulations (GVP modules, 21 CFR 312/314, ICH E2 series).
• 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.
• Experience coordinating DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, safety labels.
• Proficiency with MedDRA, WHODRUG.

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 due diligence.
• Support negotiation and maintenance of contracts, SOWs, PVAs/SDEAs.
• Track and report KPIs and SLAs (case timeliness, quality, backlog, ICSR compliance).
• Monitor vendor adherence to PV regulations; escalate compliance risks to PV leadership.
• Oversee vendor AE/SAE/SUSAR activities and escalate issues to safety leadership.
• Develop and maintain SOPs, forms, templates and guidelines for PV compliance.
• Facilitate governance meetings; drive issues, risks and CAPAs.
• Oversee vendor budgets, invoicing, forecasting, and out-of-scope work.
• Coordinate with QA on audits, CAPAs, and inspection readiness.
• Support onboarding/training of vendors and data migration.
• Assist in regulatory inspections with PV oversight.
• Coordinate PV training company-wide.

Skills

Vendor management

Cross-functional collaboration

Contract management

Regulatory awareness

Project management

Education

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

Advanced degree a plus

Tools

Argus safety database

MS Office

MS Excel

Job description

Precigen is a commercial-stage biopharmaceutical company focused on precision medicines. We seek a Manager, Drug Safety Operations to oversee day-to-day pharmacovigilance activities, vendor performance, and compliance with GVP, FDA, EMA and ICH guidelines.

You will partner with PV leadership to ensure safe, compliant operations and successful regulatory interactions. The role requires coordinating vendor activities, managing budgets, and helping implement risk management processes across