Director/Sr. Director, Pharmacovigilance & Safety
Ocugen
9 days ago
On-site
Malvern, PA
Medical Affairs
Responsibilities
- Serve as lead safety physician for assigned programs; provide medical judgment on causality, expectedness, seriousness, and clinical significance of adverse events.
- Author/review clinical narratives for SAEs, SUSARs, and AESIs.
- Lead benefit–risk assessments and ongoing product safety evaluations across the lifecycle.
- Provide safety input to protocols, informed consent, Investigator Brochures, clinical study reports, and integrated safety summaries (ISS).
- Author/review aggregate safety reports (DSURs, PSURs/PBRERs, IND annual reports, IB safety updates, health authority responses).
- Maintain AESI, targeted medical events (TMEs), and pre-specified safety endpoints.
- Develop and maintain ocular gene therapy safety surveillance strategies (e.g., intraocular inflammation, chorioretinal atrophy, RPE changes; procedure-related events from subretinal/suprachoroidal delivery).
- Oversee AAV immunogenicity monitoring (neutralizing antibodies, T-cell responses), vector shedding, and rcAAV considerations.
- Adjudicate procedure- vs product-related events, including bilateral/contralateral-eye considerations; apply ophthalmic AE grading standards.
- Oversee long-term safety follow-up (LTFU) per FDA CBER guidance and ICH expectations.
- Lead global PV operations: compliant AE/SAE/SUSAR/pregnancy/product complaint reporting; own PSMF, Safety Management Plans, SDEAs, and PV SOPs.
- Monitor PV compliance metrics; ensure safety database integrity and MedDRA coding quality.
- Lead signal detection, chair internal safety reviews, drive RMP/REMS development.
- Support DSMB/IDMC interface; prepare materials and operationalize recommendations.
- Support regulatory interactions (clinical holds, FDA Type B/C meetings).
- Oversee PV vendors, manage SLAs/KPIs/quality oversight; lead inspection readiness and CAPA/audit responses.
- Provide safety input to regulatory submissions, SEC risk disclosures, executive/Audit Committee briefings; deliver safety training; implement evolving PV regulations.
Qualifications
- MD or DO required; ophthalmology/internal medicine (or related) training preferred.
- 7 years (Director) or 10 years (Sr. Director) pharmacovigilance/drug safety experience in biotech/pharma, including hands-on safety physician responsibilities.
- Demonstrated authorship/review of DSURs, PSURs/PBRERs, RMPs, and safety sections of IBs/CSRs.
- Knowledge of FDA 21 CFR (312, 314, 600, 1271), EU GVP, ICH E2A–E2F, MedDRA, CIOMS.
- Experience with IND and BLA/MAA safety input.
- Demonstrated experience supporting regulatory inspections (FDA/EMA/MHRA/PMDA).
- Experience overseeing PV CROs/vendors and safety databases (e.g., Argus, ArisGlobal LSMV).
- Excellent written/verbal communication; strong organizational/analytical/problem-solving skills.
Preferred Qualifications
- Safety physician experience in gene therapy/cell therapy/ATMPs, especially AAV programs.
- Ophthalmology/retinal disease/rare ophthalmic disease experience.
- Experience with publicly traded sponsors (SOX, material disclosure, audit committee interactions).
- Familiarity with NEI/SUN ophthalmic AE grading.
- Experience contributing to first-in-human or pivotal gene therapy safety strategy.
- Serve as lead safety physician for assigned programs; provide medical judgment on causality, expectedness, seriousness, and clinical significance of adverse events.
- Author/review clinical narratives for SAEs, SUSARs, and AESIs.
- Lead benefit–risk assessments and ongoing product safety evaluations across the lifecycle.
- Provide safety input to protocols, informed consent, Investigator Brochures, clinical study reports, and integrated safety summaries (ISS).
- Author/review aggregate safety reports (DSURs, PSURs/PBRERs, IND annual reports, IB safety updates, health authority responses).
- Maintain AESI, targeted medical events (TMEs), and pre-specified safety endpoints.
- Develop and maintain ocular gene therapy safety surveillance strategies (e.g., intraocular inflammation, chorioretinal atrophy, RPE changes; procedure-related events from subretinal/suprachoroidal delivery).
- Oversee AAV immunogenicity monitoring (neutralizing antibodies, T-cell responses), vector shedding, and rcAAV considerations.
- Adjudicate procedure- vs product-related events, including bilateral/contralateral-eye considerations; apply ophthalmic AE grading standards.
- Oversee long-term safety follow-up (LTFU) per FDA CBER guidance and ICH expectations.
- Lead global PV operations: compliant AE/SAE/SUSAR/pregnancy/product complaint reporting; own PSMF, Safety Management Plans, SDEAs, and PV SOPs.
- Monitor PV compliance metrics; ensure safety database integrity and MedDRA coding quality.
- Lead signal detection, chair internal safety reviews, drive RMP/REMS development.
- Support DSMB/IDMC interface; prepare materials and operationalize recommendations.
- Support regulatory interactions (clinical holds, FDA Type B/C meetings).
- Oversee PV vendors, manage SLAs/KPIs/quality oversight; lead inspection readiness and CAPA/audit responses.
- Provide safety input to regulatory submissions, SEC risk disclosures, executive/Audit Committee briefings; deliver safety training; implement evolving PV regulations.
Qualifications
- MD or DO required; ophthalmology/internal medicine (or related) training preferred.
- 7 years (Director) or 10 years (Sr. Director) pharmacovigilance/drug safety experience in biotech/pharma, including hands-on safety physician responsibilities.
- Demonstrated authorship/review of DSURs, PSURs/PBRERs, RMPs, and safety sections of IBs/CSRs.
- Knowledge of FDA 21 CFR (312, 314, 600, 1271), EU GVP, ICH E2A–E2F, MedDRA, CIOMS.
- Experience with IND and BLA/MAA safety input.
- Demonstrated experience supporting regulatory inspections (FDA/EMA/MHRA/PMDA).
- Experience overseeing PV CROs/vendors and safety databases (e.g., Argus, ArisGlobal LSMV).
- Excellent written/verbal communication; strong organizational/analytical/problem-solving skills.
Preferred Qualifications
- Safety physician experience in gene therapy/cell therapy/ATMPs, especially AAV programs.
- Ophthalmology/retinal disease/rare ophthalmic disease experience.
- Experience with publicly traded sponsors (SOX, material disclosure, audit committee interactions).
- Familiarity with NEI/SUN ophthalmic AE grading.
- Experience contributing to first-in-human or pivotal gene therapy safety strategy.