Overview As Director/Head of Pharmacovigilance, you will lead the safety function for Orca Bio's cell therapy programs, guiding a dedicated team and ensuring end-to-end safety oversight. You will shape risk management, safety content for regulatory documents, and inspection readiness to support clinical development and regulatory success. You'll collaborate across functions to address resource needs, budgets, and process improvements, aligning safety activities with product development. This role offers a chance to impact patient outcomes by advancing safer, high-precision therapies in a fast-paced biotech setting. You will work in a mission-driven, start-up culture where urgency and scientific rigor
Compensation / Benefits- pre-IPO equity
- annual bonus
- remote-friendly/hybrid work
- medical, dental, and vision benefits
- PTO
- 401(k) plan
Responsibilities- Lead risk management and mitigation activities for assigned products, including safety data review and analysis
- Provide safety content for clinical and regulatory documents
- Lead inspection preparedness for pharmacovigilance and represent PV at regulatory inspections
- Update SOPs and documentation to address process gaps in light of regulatory changes
- Identify resource and infrastructure needs; contribute to budgets and planning
- Represent product safety in cross-functional teams
- Lead safety governance with medical monitors and leadership
- Support regulatory filings (RMPs, REMs, ISS, safety labeling) and preparation for meetings
- Mentor and oversee pharmacovigilance staff and operations
Key requirements- 10+ years in drug safety, safety science, and risk management with leadership experience
- Advanced degree in biologic/medical/clinical/nursing field (Pharmacist/PharmD, NP, MD, or PhD)
- Knowledge of US/EU safety regulations (pre/post marketing PV)
- Experience with PV risk management at a commercial-stage company
- Proficiency in PSURs, PBRERs, PADER, and Risk Management Plans
- Experience with clinical development, risk/benefit analysis, and safety assessment
- Strong clinical, analytical, problem-solving, scientific writing, and communication skills
- Prior experience with BLA/NDA, and leading risk management activities for BLA/NDA preferred
- Hands-on in small biotech environments; knowledge of cell therapy, bone marrow transplant, or hematology/oncology a plus
- Experience with safety data analysis, MedDRA coding and search strategies
- Excellent independent judgment and strong time/project management skills
- Strong communication
- Analytical mindset
- Problem-solving ability
- Pharmacovigilance risk management
- Regulatory document preparation (PSURs, PBRERs, PADER, RMPs)
- Safety signal detection and risk identification
