Drug Safety Operations Lead - Vendor Oversight & Compliance

Precigen, Inc; Germantown (MD); Vor Ort; USD 120.000 - 135.000; Vollzeit

Zusammenfassung

Precigen, Inc. is seeking a Manager of Drug Safety Operations to oversee day-to-day pharmacovigilance activities and manage external PV service providers from Germantown, MD.

You will coordinate vendor activities, ensure regulatory compliance, and support safety reporting and inspections. The role requires 3–5 years in pharmacovigilance with vendor oversight, knowledge of GVP and 21 CFR regulations, and experience with safety databases like Argus.

Qualifikationen

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field required.
• 3–5 years in pharmacovigilance or drug safety, including vendor or outsourcing oversight.
• Experience in supporting regulatory authority 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 supporting interactions with the QPPV and EMA, including EU GVP oversight.

Aufgaben

• Manage day-to-day relationships with PV vendors and act as primary operational contact.
• Coordinate vendor selection activities (RFPs, bid defenses, due diligence) with PV leadership.
• Support negotiation and maintenance of PV contracts, SOWs, PVAs/SDEAs.
• Track KPIs and SLAs (e.g., case timeliness, backlog, quality scores).
• Monitor vendor compliance with US and international PV regulations; escalate risks.
• Oversee vendor AE, SAE, and SUSAR activities and escalate issues to leadership.
• Contribute to SOPs, templates, and guidelines to ensure compliance.
• Support regulatory inspections and audits as operational PV subject matter resource.

Kenntnisse

Vendor management

Communication

Negotiation

Stakeholder management

Ausbildung

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

Argus

DSUR processing tools

Jobbeschreibung

Precigen, Inc. is seeking a Manager of Drug Safety Operations to oversee day-to-day pharmacovigilance activities and manage external PV service providers from Germantown, MD.

You will coordinate vendor activities, ensure regulatory compliance, and support safety reporting and inspections. The role requires 3–5 years in pharmacovigilance with vendor oversight, knowledge of GVP and 21 CFR regulations, and experience with safety databases like Argus.