Senior Director – Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the internal pharmacovigilance expert and safety medical lead for BBOT.

• Offer medical and scientific supervision of safety data throughout the clinical portfolio.

• Direct safety surveillance, signal detection, and medical evaluation of ICSRs, SAEs, and SUSARs.

• Chair meetings for the Safety Review Team and manage safety monitoring plans, risk-management strategies, and benefit-risk frameworks.

• Write and review safety documentation for INDs, IBs, DSURs, annual safety reports, REMS, RMPs, and NDA/BLA safety sections.

• Represent BBOT in safety-related discussions with the FDA, EMA, and other international health authorities.

• Collaborate on protocol design, informed consent forms, safety stopping rules, dose escalation criteria, and emerging safety signals.

• Develop and enhance the pharmacovigilance system, including workflows for adverse-event collection, processing, and reporting.

• Ensure the prompt reporting of ICSRs, expedited reports, and aggregate safety reports.

• Create SOPs, work instructions, and training materials; lead inspection readiness and act as the PV contact during audits and inspections.

• Supervise PVAs and SDEAs in collaboration with CROs, partners, and collaborators.

• Establish compliance metrics and address process, system, and documentation gaps.

• Support the implementation and oversight of the safety database.

• Select, onboard, and manage PV CROs and safety vendors.

• Oversee vendor scopes, performance metrics, governance frameworks, oversight meetings, and quality evaluations.

• Collaborate with Clinical Operations, Regulatory Affairs, Data Management, and Biostatistics on the integration, coding, and reporting of safety data.

• Act as the safety lead on cross-functional program teams and contribute to development plans, risk mitigation, and safety go/no-go decisions.

• Assist with DSMB/DMC charters, processes, outputs, safety data packages, and safety narratives.

• Build BBOT’s pharmacovigilance function, infrastructure, systems, processes, and vendor relationships.

• Recruit, develop, and lead the pharmacovigilance team as the pipeline expands.

• Provide pharmacovigilance insights for corporate strategy, pipeline risk, regulatory strategy, and safety go/no-go criteria.

⛳️ Requirements

• M.D., D.O., or equivalent degree is preferred; candidates with a PharmD or Ph.D. and substantial medical safety leadership experience will also be considered.

• For Senior Director: a minimum of 10 years of progressive experience in pharmacovigilance and/or drug safety within the biopharmaceutical sector, with at least 5 years in a leadership or senior lead role.

• For Executive Director: a minimum of 12 years of progressive experience in pharmacovigilance and/or drug safety within the biopharmaceutical sector, with at least 5 years in a senior leadership or function-head role.

• Proficient in safety science and safety operations.

• Experience in oncology is required; early-phase oncology experience is strongly preferred.

• Knowledge of FDA 21 CFR Parts 312 and 314, EMA GVP modules, ICH E2A–E2F, and MedDRA/WHO DD coding standards.

• Experience overseeing PV CROs and safety vendors.

• Proven experience in authoring and reviewing PV regulatory documents, including DSURs, IB safety updates, IND annual reports, and safety-related submissions.

• Experience supporting or participating in interactions with the FDA, EMA, or other health authorities.

• Familiarity with Argus, Veeva Vault Safety, or ArisGlobal and other safety reporting systems.

• Strong communication skills and ability to collaborate across functions.

• Prior experience in lean, startup, or high-growth biotech environments is highly desirable.

• For Executive Director: experience in establishing or significantly developing a pharmacovigilance function at a lean biotech or as an early PV hire.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance.

• Competitive salary with performance-based bonuses.

• Opportunities for professional development and continuing education.

• Flexible work environment with remote options available.

• Generous vacation and leave policies.