Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies utilizing the company’s AdenoVerse® and UltraCAR-T® therapeutic platforms across its core focus areas of immuno-oncology, autoimmune disorders, and infectious diseases.
POSITION SUMMARY:
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.
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in life sciences, nursing, pharmacy, or a related field (advanced degree a plus)
- 3-5 years in pharmacovigilance or drug safety, including vendor or outsourcing oversight
- Experience in supporting regulatory authority inspections required.
- 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 ensuring that outsourced PV activities are performed in line with EU GVP and QPPV oversight expectations.
- Experience supporting the preparation, coordination, or operational review of safety documents such as DSURs, Investigator’s Brochure (IB), Periodic Benefit-Risk Evaluation Report (PBRERs)/PADERs, responses to Health Authority requests, submission documents and safety labels.
- Proficiency with safety coding dictionaries (eg, MedDRA, WHODRUG).
DESIRED KEY COMPETENCIES:
- Self-organizer, highly motivated, and keen attention to detail.
- Ability to understand and execute the company’s mission and values.
- Maintain a high degree of ethical standard and trustworthiness.
- Exhibits an open mindset when approaching challenges and conflict.
- Ability to think and adapt to a rapidly changing environment and demands.
- Strong time management and organizational skills.
- Strong contract, budget, and metrics management skills
- Excellent communication, negotiation, stakeholder management and cross-functional collaboration abilities.
- Ability to evaluate, interpret and synthesize scientific data.
- Team player with ability to work cross-functionally in a highly virtual environment.
- Strong vendor management and communication skills.
- Well organized self-starter, able to handle multiple priorities and work across all levels of an organization.
- Exhibits impeccable confidentiality on sensitive, supporting tasks.
- Ability to anticipate and solve problems while analyzing complex issues and environments.
- Ability to adapt and succeed in a milestone-driven, rapidly changing product development and commercialization environment.
- Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF
