Director, Safety & Pharmacovigilance (PV)
Ocugen
August 31, 2026
On-site
Malvern, PA
Medical Affairs
Responsibilities:
- Serve as the safety physician for assigned programs, assessing adverse events (seriousness, expectedness, causality, and clinical significance).
- Personally review and approve SAEs, SUSARs, AESIs, pregnancy cases, and other medically significant safety narratives.
- Review emerging and cumulative safety data; evaluate potential signals; recommend follow-up and risk-mitigation actions.
- Lead benefit–risk assessments and communicate conclusions to cross-functional teams and senior leadership.
- Provide safety input to protocols, informed consent forms, Investigator Brochures, clinical study reports, and regulatory submissions.
- Author or medically review DSURs, IND annual reports, Investigator Brochure safety updates, aggregate reports, and health authority responses.
- Develop and maintain ocular gene therapy safety surveillance strategies (ocular inflammation, procedure-related events, immunogenicity, vector shedding, long-term follow-up).
- Direct day-to-day PV activities (case processing, medical review, reconciliation, regulatory reporting).
- Maintain Safety Management Plans, safety data exchange agreements, PV procedures, and inspection-ready documentation.
- Lead signal detection and internal safety review; support DSMB/IDMC meetings.
- Provide sponsor oversight of PV vendors; lead/support PV audits and inspections; manage deviations/CAPAs and process improvements.
- Escalate significant safety/compliance risks promptly; provide safety training.
Qualifications:
- MD or DO strongly preferred.
- 7+ years pharmacovigilance/drug safety experience in biotech/pharma, including hands-on safety physician responsibilities.
- Experience assessing complex cases, aggregate safety data, and leading signal and benefit–risk activities.
- Experience authoring/medically reviewing DSURs, IND annual reports, Investigator Brochure safety sections, clinical study reports, and regulatory responses.
- Working knowledge of FDA regulations, EU GVP, ICH E2, MedDRA, and CIOMS conventions.
- Experience overseeing PV CROs, case-processing vendors, and safety database activities; supporting regulatory inspections/PV audits.
- Strong judgment, communication, and organizational skills; ability to work independently and cross-functionally.
- Willingness to personally execute critical safety work.
Preferred:
- Gene/cell therapy experience, especially AAV-based programs.
- Ophthalmology/retinal disease/rare disease experience.
- Experience supporting pivotal-stage programs, BLA/MAA preparation, or long-term gene therapy follow-up.
- Experience with Argus, ArisGlobal LifeSphere, or comparable safety databases.
- Serve as the safety physician for assigned programs, assessing adverse events (seriousness, expectedness, causality, and clinical significance).
- Personally review and approve SAEs, SUSARs, AESIs, pregnancy cases, and other medically significant safety narratives.
- Review emerging and cumulative safety data; evaluate potential signals; recommend follow-up and risk-mitigation actions.
- Lead benefit–risk assessments and communicate conclusions to cross-functional teams and senior leadership.
- Provide safety input to protocols, informed consent forms, Investigator Brochures, clinical study reports, and regulatory submissions.
- Author or medically review DSURs, IND annual reports, Investigator Brochure safety updates, aggregate reports, and health authority responses.
- Develop and maintain ocular gene therapy safety surveillance strategies (ocular inflammation, procedure-related events, immunogenicity, vector shedding, long-term follow-up).
- Direct day-to-day PV activities (case processing, medical review, reconciliation, regulatory reporting).
- Maintain Safety Management Plans, safety data exchange agreements, PV procedures, and inspection-ready documentation.
- Lead signal detection and internal safety review; support DSMB/IDMC meetings.
- Provide sponsor oversight of PV vendors; lead/support PV audits and inspections; manage deviations/CAPAs and process improvements.
- Escalate significant safety/compliance risks promptly; provide safety training.
Qualifications:
- MD or DO strongly preferred.
- 7+ years pharmacovigilance/drug safety experience in biotech/pharma, including hands-on safety physician responsibilities.
- Experience assessing complex cases, aggregate safety data, and leading signal and benefit–risk activities.
- Experience authoring/medically reviewing DSURs, IND annual reports, Investigator Brochure safety sections, clinical study reports, and regulatory responses.
- Working knowledge of FDA regulations, EU GVP, ICH E2, MedDRA, and CIOMS conventions.
- Experience overseeing PV CROs, case-processing vendors, and safety database activities; supporting regulatory inspections/PV audits.
- Strong judgment, communication, and organizational skills; ability to work independently and cross-functionally.
- Willingness to personally execute critical safety work.
Preferred:
- Gene/cell therapy experience, especially AAV-based programs.
- Ophthalmology/retinal disease/rare disease experience.
- Experience supporting pivotal-stage programs, BLA/MAA preparation, or long-term gene therapy follow-up.
- Experience with Argus, ArisGlobal LifeSphere, or comparable safety databases.