Manager, Drug Safety Operations

Precigen, Inc•Germantown, MD

1d•$120,000 - $135,000

About The Position

Precigen is seeking a Manager, Drug Safety Operations reporting to the Senior Medical Director, Development and Pharmacovigilance. The role supports day-to-day pharmacovigilance activities through oversight of external PV service providers and serves as the primary operational point of contact for PV vendors. The Manager helps ensure safety operations comply with applicable regulations, contractual obligations, and company procedures. 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 established risk-management and pharmacovigilance processes for Precigen products.

Requirements

Bachelor’s degree in life sciences, nursing, pharmacy, or a related field.
3–5 years of experience in pharmacovigilance or drug safety, including vendor or outsourcing oversight.
Experience supporting regulatory authority inspections.
Working knowledge of global PV regulations, including GVP modules, 21 CFR 312/314, and the ICH E2 series.
Experience with safety databases such as Argus and with 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 ensuring outsourced PV activities meet EU GVP and QPPV oversight expectations.
Experience supporting preparation, coordination, or operational review of safety documents, including DSURs, Investigator’s Brochures, PBRERs/PADERs, responses to Health Authority requests, submission documents, and safety labels.
Proficiency with safety coding dictionaries such as MedDRA and WHODRUG.
Strong attention to detail, time management, organizational, contract, budget, and metrics management skills.
Excellent communication, negotiation, stakeholder management, cross-functional collaboration, and vendor management skills.
Ability to evaluate, interpret, and synthesize scientific data.
Ability to work cross-functionally in a highly virtual environment, manage multiple priorities, and work across organizational levels.
Ability to anticipate and solve problems, analyze complex issues, and adapt to a rapidly changing, milestone-driven product development and commercialization environment.
High ethical standards, trustworthiness, and discretion with confidential information.
Computer proficiency, including Microsoft Word, Outlook, Excel, and Adobe PDF.

Nice To Haves

An advanced degree.

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, with PV leadership and internal stakeholders.
Support negotiation and maintenance of contracts, statements of work, change orders, and Pharmacovigilance Agreements (PVAs/SDEAs).
Track and report KPIs and SLAs, including case timeliness, quality scores, backlog, and ICSR compliance rates.
Monitor vendor adherence to applicable US and international PV regulations and adverse-event reporting requirements; escalate compliance risks to PV leadership.
Manage the operational execution of vendor-performed AE, SAE, and SUSAR activities, escalating significant case or compliance issues to PV and medical safety leadership.
Contribute to the development and maintenance of SOPs, forms, templates, guidelines, and work instructions.
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 for compliance with GVP, FDA, EMA, ICH, and local regulations; escalate identified gaps to PV leadership and QA.
Support vendor onboarding, training, transitions, offboarding, and data migration.
Contribute to vendor oversight plans.
Support regulatory inspections and audits as 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 leadership-led signal management and benefit-risk activities, including coordinating vendor data and deliverables such as PADERs and DSURs.
Perform other duties as assigned.