Head of Pharmacovigilance

Job Summary:
Head of Pharmacovigilance (PV) responsible for leadership and oversight of Pharmacovigilance and Safety across development, global launches, and post-market products. Sits on the CMO leadership team and reports to the Chief Medical Officer.

Essential Functions:
Biological Product Safety
- Provide medical oversight of PV, including review of AE/SAE case narratives and causality assessments.
- Maintain signal detection (regular/ad hoc aggregate safety data reviews).
- Coordinate safety governance and cross-functional evaluation of emerging safety issues, including risk mitigation.
- Support benefit-risk assessments.
- Communicate with health/regulatory authorities (manage DSUR; sign DSUR, PAER and other safety reports to FDA and other authorities).
- Represent PV at Data Safety Monitoring Committee meetings.
- Design and implement risk management plans.
- Author/review/approve drug-safety regulatory reports and clinical study documents (e.g., protocols, informed consent forms, IB, ISS/ISE, labeling, Company Core Safety Information).

Oversight of Safety Operations
- Work with CROs on clinical conduct and safety processes.
- Manage drug safety operations staff for case management, process optimization, case quality, and regulatory reporting.
- Define PV signal management processes/analytics/tools in line with GVP.

Safety Quality Metrics
- Ensure GVP inspection readiness.
- Ensure PV system compliance with cross-functional stakeholders.
- Oversee GVP/GxP procedures and drug-safety compliance.
- Plan and document internal/external GVP/GxP audits with Quality; support audits of contractual partners.
- Identify procedural gaps and implement improvements; oversee PV process/project management.

Managerial Responsibilities
- Lead PV team (2–5 direct reports); develop operating plans/budgets; meet performance/schedule goals.

Experience & Qualifications (Required/Preferred):
- MD (or non-US equivalent) with 12+ years biotech/pharma industry experience required; other clinical degrees (RN, MSN, NP, PhD) may be considered; mix of large/small company experience preferred.
- Knowledge of GCP, clinical trial conduct, data interpretation, and clinical development safety.
- Extensive experience interfacing with US health authorities on safety/pharmacovigilance.
- Experience with BLA/sBLA submissions.
- PV experience for clinical development and post-marketed products.
- Strong scientific/clinical/analytical capability; causality assessment expertise.
- Expert/regulatory knowledge of pharmacovigilance; safety science/operations and safety systems/databases.
- Direct management experience; strong communication/writing and can-do problem-solving.
- Minimal business travel; travel to Durham HQs for key meetings.

Compensation & Benefits Highlights:
- Stock options; 401(k) with 4% match; medical/vision/dental; company-paid disability and life insurance; 23 days PTO; 10 company holidays + 2 floating; paid parental leave.

Application Instructions:
- No unsolicited resumes from third-party firms/agency recruiters; no US employment sponsorship.