Director/Sr. Director, Pharmacovigilance & Safety

Responsibilities

• Medical Safety Leadership (Safety Physician)
• Serve as the lead safety physician for assigned programs; provide medical judgment on causality, expectedness, seriousness, and clinical significance of all adverse events.
• Author and medically review clinical narratives for SAEs, SUSARs, and adverse events of special interest (AESI).
• Lead benefit–risk assessments and ongoing product safety evaluations throughout the product lifecycle.
• Provide safety input to clinical protocols, informed consent forms, Investigator Brochures, clinical study reports, and integrated safety summaries (ISS).
• Define and maintain program-level lists of AESIs, Targeted Medical Events (TMEs), and pre-specified safety endpoints.
• Gene Therapy and Ophthalmology-Specific Safety
• Develop and maintain program-specific safety surveillance strategies addressing the unique risk profile of ocular gene therapy, including intraocular inflammation (uveitis, vitritis, retinitis, endophthalmitis), chorioretinal atrophy, RPE changes, and procedure-related events from subretinal or suprachoroidal delivery.
• Provide medical oversight of AAV-related immunogenicity monitoring (pre-existing and treatment-emergent neutralizing antibodies, T-cell responses), vector shedding analyses, and replication-competent AAV (rcAAV) considerations.
• Oversee long-term safety follow-up (LTFU) studies and registry programs consistent with FDA CBER 5–15 year gene therapy follow-up guidance and applicable ICH expectations.
• Pharmacovigilance Operations and Compliance
• Ensure compliant intake, processing, medical review, and expedited and periodic reporting of AEs, SAEs, SUSARs, pregnancies, special situations, and product complaints in accordance with FDA, EMA, and other applicable authorities.
• Own the Pharmacovigilance System Master File (PSMF), Safety Management Plans, Safety Data Exchange Agreements (SDEAs), and PV SOPs; ensure they remain current and inspection-ready.
• Maintain compliance metrics (case timeliness, late-case rate, reconciliation status, query turnaround); investigate and remediate quality or regulatory risks.
• Ensure integrity, accuracy, and completeness of the safety database; oversee MedDRA coding quality and consistency.
• Signal Detection, Risk Management, and DSMB Support
• Lead routine and ad hoc signal detection activities; convene and chair internal safety review meetings.
• Drive Risk Management Plan (RMP) and, where applicable, REMS development as programs advance toward BLA.
• Support clinical hold responses, FDA Type B/C meetings, and other health authority interactions.
• Vendor Oversight and Inspection Readiness
• Manage PV CROs, case processing vendors, and safety service providers; monitor compliance and respond to CAPAs, deviations, and audits.
• Prepare data review packages and operationalize DSMB recommendations.
• Cross-Functional Leadership and Public Company Support
• Partner with Regulatory Affairs, Clinical Development, Medical Affairs, Quality, Legal, and Investor Relations to ensure safety information is appropriately integrated into regulatory submissions, study communications, and external disclosures.
• Contribute to material event assessments, risk factor disclosures in periodic SEC filings, and safety briefings to executive leadership and the Audit Committee or full Board as requested.
• Train internal teams, investigators, and vendors on protocol-specific reporting obligations and PV procedures.

Qualifications

• MD or DO required. Active or prior clinical practice experience strongly preferred; subspecialty training in ophthalmology, internal medicine, or a related discipline is highly desirable, particularly at the Sr. Director level.
• Minimum 7 years (Director) or 10 years (Sr. Director) of pharmacovigilance / drug safety experience in the biotechnology or pharmaceutical industry, including direct hands-on safety physician responsibilities.
• Demonstrated authorship and medical review of DSURs, PSURs/PBRERs, RMPs, Investigator Brochure safety sections, and CSR safety sections.
• Working knowledge of FDA (21 CFR Parts 312, 314, 600, 1271), EU GVP modules, ICH E2A–E2F, MedDRA, and CIOMS conventions.
• Experience providing safety input to IND, IND amendment, and BLA / MAA submissions.
• Demonstrated experience leading or substantively supporting regulatory inspections (FDA, EMA, MHRA, PMDA).
• Experience overseeing PV CROs, case processing vendors, and safety database operations (e.g., Argus, ArisGlobal LSMV).
• Excellent written and verbal communication skills; ability to translate complex medical and safety issues into clear, executive-level summaries.
• Strong organizational, analytical, and problem-solving skills; demonstrated ability to manage multiple priorities in a fast-paced, resource-constrained biotech environment.

Preferred Qualifications

• Direct safety physician experience with gene therapy, cell therapy, or other advanced therapy medicinal products (ATMPs), particularly AAV-based programs.
• Ophthalmology, retinal disease, or rare ophthalmic disease therapeutic experience.
• Prior experience supporting a publicly traded sponsor, including familiarity with SOX, material event disclosure processes, and audit committee interactions.
• Familiarity with NEI ophthalmic AE grading conventions and SUN uveitis grading.
• Experience contributing to first-in-human or pivotal trial safety strategy for gene therapy products.