What are the responsibilities and job description for the Director, Safety & Pharmacovigilance (PV) position at BioSpace?
Position
The Director, Pharmacovigilance & Patient Safety provides medical and operational leadership for safety activities across Ocugen’s clinical-stage portfolio of ocular gene therapies. This hands-on role is responsible for safety surveillance, case assessment, signal detection, benefit–risk evaluation, aggregate reporting, vendor oversight, and inspection readiness.
The Director works closely with Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Quality Assurance, and external vendors to ensure safety risks are identified, evaluated, communicated, and addressed promptly.
Responsibilities
Serve as the safety physician for assigned programs, providing medical assessment of adverse events, including 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, and recommend appropriate follow-up or risk-mitigation actions.
Lead benefit–risk assessments and communicate conclusions and recommendations 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 program-specific safety surveillance strategies for ocular gene therapy, including ocular inflammation, procedure-related events, immunogenicity, vector shedding, and long-term follow-up.
Direct day-to-day PV activities, ensuring accurate and timely case processing, medical review, reconciliation, and regulatory reporting.
Maintain Safety Management Plans, Safety Data Exchange Agreements, PV procedures, and inspection-ready documentation.
Lead signal-detection and internal safety-review activities and support DSMB/IDMC meetings and recommendations.
Provide active sponsor oversight of PV vendors, including review of quality, timelines, compliance metrics, and corrective actions.
Lead or support PV audits, inspections, deviations, CAPAs, and process improvements.
Escalate significant safety or compliance risks promptly, with a clear assessment and recommended action.
Provide safety training to employees, investigators, and vendors as needed.
MD or DO strongly preferred.
At least seven years of pharmacovigilance or drug safety experience in the biotechnology or pharmaceutical industry, including hands-on safety physician responsibilities.
Demonstrated experience assessing complex cases, evaluating aggregate safety data, and leading signal and benefit–risk activities.
Experience authoring or 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 guidance, MedDRA, and CIOMS conventions.
Experience overseeing PV CROs, case-processing vendors, and safety database activities.
Experience supporting regulatory inspections or PV audits.
Strong judgment, communication, and organizational skills, with the ability to work both independently and cross-functionally in a fast-paced biotech environment.
Willingness to personally execute critical safety work rather than relying solely on vendors or larger teams.
Preferred
Gene therapy, cell therapy, or other advanced therapy experience, particularly with AAV-based programs.
Ophthalmology, retinal disease, or rare disease experience.
Experience supporting pivotal-stage programs, BLA/MAA preparation, or long-term gene therapy follow-up.
Experience with Argus, ArisGlobal LifeSphere, or a comparable safety database.
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.
The Director, Pharmacovigilance & Patient Safety provides medical and operational leadership for safety activities across Ocugen’s clinical-stage portfolio of ocular gene therapies. This hands-on role is responsible for safety surveillance, case assessment, signal detection, benefit–risk evaluation, aggregate reporting, vendor oversight, and inspection readiness.
The Director works closely with Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Quality Assurance, and external vendors to ensure safety risks are identified, evaluated, communicated, and addressed promptly.
Responsibilities
Serve as the safety physician for assigned programs, providing medical assessment of adverse events, including 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, and recommend appropriate follow-up or risk-mitigation actions.
Lead benefit–risk assessments and communicate conclusions and recommendations 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 program-specific safety surveillance strategies for ocular gene therapy, including ocular inflammation, procedure-related events, immunogenicity, vector shedding, and long-term follow-up.
Direct day-to-day PV activities, ensuring accurate and timely case processing, medical review, reconciliation, and regulatory reporting.
Maintain Safety Management Plans, Safety Data Exchange Agreements, PV procedures, and inspection-ready documentation.
Lead signal-detection and internal safety-review activities and support DSMB/IDMC meetings and recommendations.
Provide active sponsor oversight of PV vendors, including review of quality, timelines, compliance metrics, and corrective actions.
Lead or support PV audits, inspections, deviations, CAPAs, and process improvements.
Escalate significant safety or compliance risks promptly, with a clear assessment and recommended action.
Provide safety training to employees, investigators, and vendors as needed.
MD or DO strongly preferred.
At least seven years of pharmacovigilance or drug safety experience in the biotechnology or pharmaceutical industry, including hands-on safety physician responsibilities.
Demonstrated experience assessing complex cases, evaluating aggregate safety data, and leading signal and benefit–risk activities.
Experience authoring or 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 guidance, MedDRA, and CIOMS conventions.
Experience overseeing PV CROs, case-processing vendors, and safety database activities.
Experience supporting regulatory inspections or PV audits.
Strong judgment, communication, and organizational skills, with the ability to work both independently and cross-functionally in a fast-paced biotech environment.
Willingness to personally execute critical safety work rather than relying solely on vendors or larger teams.
Preferred
Gene therapy, cell therapy, or other advanced therapy experience, particularly with AAV-based programs.
Ophthalmology, retinal disease, or rare disease experience.
Experience supporting pivotal-stage programs, BLA/MAA preparation, or long-term gene therapy follow-up.
Experience with Argus, ArisGlobal LifeSphere, or a comparable safety database.
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.