Director/Sr. Director, Pharmacovigilance & Safety

Position Summary

The Director / Sr. Director, Pharmacovigilance & Drug Safety serves as Ocugen's head of pharmacovigilance and lead safety physician across the company's clinical-stage portfolio of ocular gene therapies, including OCU400 (retinitis pigmentosa), OCU410 (geographic atrophy), and OCU410ST (Stargardt disease). The incumbent provides medical leadership and operational accountability for the global PV system-ICSR management, signal detection, benefit-risk evaluation, aggregate safety reporting, vendor oversight, and inspection readiness-with particular focus on the distinct safety considerations of subretinal and intravitreal administration, AAV-related immunogenicity, and long-term follow-up under FDA CBER guidance.

As a leader within a publicly traded biotechnology company, this role also supports timely and accurate safety input to executive leadership, the Board of Directors, and external disclosures. The position partners closely with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, Medical Affairs, Quality Assurance, Legal, and external CROs and PV vendors.

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).
• Serve as medical author and reviewer of aggregate safety reports, including DSURs, PSURs/PBRERs, IND annual reports, IB safety updates, and health authority responses.
• 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.

• Adjudicate procedure-related versus product-related adverse events, including bilateral and contralateral-eye safety considerations.

• Apply and maintain ophthalmic AE grading standards (e.g., SUN criteria for uveitis, CTCAE Ophthalmology, NEI conventions).

• 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

• Provide strategic and operational leadership for the global PV system across clinical development and (as programs advance) post-marketing activities.

• 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.

• Monitor PV 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.
• Serve as the company safety interface with Data Safety Monitoring Boards (DSMB/IDMC); develop charters, prepare data review packages, and operationalize DSMB recommendations.
• Provide medical safety support for clinical hold responses, FDA Type B/C meetings, and other health authority interactions.

Vendor Oversight and Inspection Readiness

• Provide sponsor oversight of PV CROs, case processing vendors, and safety service providers; manage SLAs, KPIs, governance forums, and quality oversight.
• Lead PV inspection readiness; serve as subject matter expert for FDA BIMO, EMA, MHRA, and PMDA inspections.
• Oversee PV-related CAPAs, deviations, and audit responses; partner with Quality Assurance on continuous improvement.

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.
• Provide safety input 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.
• Deliver safety training to internal teams, investigators, and vendors on protocol-specific reporting obligations and PV procedures.
• Monitor evolving global PV regulations (FDA 21 CFR 312/314/600/1271, EU GVP, ICH E2A-E2F, FDA CBER gene therapy guidance) and implement updates to systems and processes.
• 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).
• Demonstrated 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.

Working Conditions

This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.