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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in pharmacovigilance and drug safety, with a strong focus on safety science, regulatory compliance, and cross-functional collaboration. Proven ability to lead safety surveillance, manage vendor relationships, and develop safety-related documentation in alignment with industry standards.
Highest-signal resume keywords
Pharmacovigilance ExpertiseSafety Operations LeadershipOncology ExperienceRegulatory Document AuthoringCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety SurveillanceSignal DetectionMedical AssessmentAdverse Event ReportingSafety Data IntegrationRisk Management StrategiesCompliance Metrics EstablishmentPharmacovigilance System ImprovementSafety Database OversightVendor Management
Soft Skills
Strong CommunicationLeadershipCollaboration
Tools & Technologies
ArgusVeeva Vault SafetyArisGlobalSafety Reporting Systems
Certifications & Qualifications
M.D.D.O.PharmDPh.D.
Industry Keywords
Biopharmaceutical IndustryFDA 21 CFR Parts 312 and 314EMA GVP ModulesICH E2A–E2FMedDRA/WHO DD Coding StandardsINDsDSURsSAEsSUSARsSafety Review Team
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Serve as BBOT’s internal pharmacovigilance subject matter expert and safety medical lead
- Provide medical and scientific oversight of safety data across the clinical portfolio
- Lead safety surveillance, signal detection, and medical assessment of ICSRs, SAEs, and SUSARs
- Chair Safety Review Team meetings and maintain safety monitoring plans, risk-management strategies, and benefit-risk frameworks
- Author and review safety content for INDs, IBs, DSURs, annual safety reports, REMS, RMPs, and NDA/BLA safety sections
- Represent BBOT in safety-related interactions with FDA, EMA, and other global health authorities
- Collaborate on protocol design, informed consent forms, safety stopping rules, dose escalation criteria, and emerging safety signals
- Establish and improve the pharmacovigilance system, including adverse-event collection, processing, and reporting workflows
- Ensure timely reporting of ICSRs, expedited reports, and aggregate safety reports
- Develop SOPs, work instructions, and training materials; lead inspection readiness and serve as PV contact during audits and inspections
- Oversee PVAs and SDEAs with CROs, partners, and collaborators
- Establish compliance metrics and remediate process, system, and documentation gaps
- Support safety database implementation and oversight
- Select, onboard, and oversee PV CROs and safety vendors
- Manage vendor scopes, performance metrics, governance frameworks, oversight meetings, and quality reviews
- Partner with Clinical Operations, Regulatory Affairs, Data Management, and Biostatistics on safety data integration, coding, and reporting
- Serve as safety lead on cross-functional program teams and contribute to development plans, risk mitigation, and safety go/no-go decisions
- Support 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 PV team as the pipeline grows
- Provide pharmacovigilance insights for corporate strategy, pipeline risk, regulatory strategy, and safety go/no-go criteria
Requirements
What you’ll need- M.D., D.O., or equivalent degree preferred; PharmD or Ph.D. candidates with significant medical safety leadership experience will be considered
- Senior Director: minimum 10 years of progressive experience in pharmacovigilance and/or drug safety within the biopharmaceutical industry, with at least 5 years in a leadership or senior lead capacity
- Executive Director: minimum 12 years of progressive experience in pharmacovigilance and/or drug safety within the biopharmaceutical industry, with at least 5 years in a senior leadership or function-head capacity
- Expertise in safety science and safety operations
- Oncology experience required; early-phase oncology experience 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
- Experience authoring and reviewing PV regulatory documents, including DSURs, IB safety updates, IND annual reports, and safety-related submissions
- Experience supporting or participating in FDA, EMA, or other health-authority interactions
- Familiarity with Argus, Veeva Vault Safety, or ArisGlobal and safety reporting systems
- Strong communication and cross-functional collaboration skills
- Prior lean, startup, or high-growth biotech experience highly desirable
- Executive Director: experience establishing or significantly building a pharmacovigilance function at a lean biotech or as an early PV hire