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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 clinical trial safety surveillance, regulatory compliance, and risk management. Proficient in authoring safety documents and managing vendor relationships within the biotechnology and pharmaceutical industries.
Highest-signal resume keywords
Pharmacovigilance Subject Matter ExpertClinical Trial Safety SurveillanceOracle Argus SafetyGlobal PV RegulationsMedical/Scientific Writing
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Case ManagementSafety Data ReconciliationSignal DetectionRisk Management PlansAggregate Safety ReportsRegulatory ReportingQuality ControlSafety Management PlansEvent AdjudicationSafety Review Committee Activities
Soft Skills
Analytical SkillsCross-Functional CommunicationMentoringIndependent PrioritizationTeam Collaboration
Tools & Technologies
Safety Database SystemsTrial Master FileQuality Metrics TrackingVendor GovernanceHealth Authority Queries
Industry Keywords
Pharmaceutical IndustryBiotechnologyICH-GCPFDAEMAGVP GuidancePost-Marketing PharmacovigilanceSafety Data Exchange AgreementsPharmacovigilance AgreementsClinical Operations
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- Serve as a pharmacovigilance subject matter expert for ongoing and future clinical trials, including Phase 1 studies and the Phase 3 PHrontier study
- Oversee end-to-end case management for serious adverse events, including intake, triage, medical review coordination, regulatory reporting, and ICSR quality control
- Maintain safety mailboxes
- Monitor expedited reporting timelines and case quality metrics
- Reconcile safety data across clinical operations, CROs, and safety vendors
- Support event adjudication, Safety Review Committee activities, and IDMCs
- Review and author safety documents, including Safety Management Plans, Investigator Brochures, protocols, informed consents, and Letters of Authorization
- Support quarterly Safety Review Committee activities and maintain signal assessment logs
- Support signal detection, validation, evaluation, and escalation
- Contribute to risk management plans and safety monitoring plans
- Review aggregate safety reports, including DSURs, six-month line listings, and ad hoc safety summaries
- Maintain reporting calendars and data-lock timelines
- Track safety-related regulatory commitments and support responses to health authority queries
- Oversee PV vendor and CRO relationships, including Oracle Argus Safety, case processing, and literature surveillance
- Manage vendor governance meetings, KPIs, quality metrics, issue escalation, and CAPA follow-up
- Support PV vendor qualification and onboarding, including PVAs
- Ensure compliance with ICH-GCP, FDA, EMA, global regulations, and GVP guidance
- Author, review, and maintain PV SOPs, work instructions, and controlled documents
- Participate in audit and inspection readiness activities
- Perform quarterly QC of the electronic Trial Master File
- Represent Pharmacovigilance in cross-functional safety management and CRO meetings
- Provide PV training and guidance to internal stakeholders and investigator sites
- Mentor junior safety staff and contribute to strategic PV planning
Requirements
What you’ll need- Bachelor's degree in life sciences, nursing, pharmacy, or related field required
- Minimum of approximately 7+ years of pharmacovigilance/drug safety experience in the biotechnology or pharmaceutical industry
- Demonstrated experience with clinical trial safety surveillance and case management
- Working knowledge of global PV regulations and guidance, including FDA, EMA, ICH E2 series, and GVP modules
- Experience authoring or contributing to DSURs, PSURs/PBRERs, and risk management plans
- Familiarity with safety database systems such as Oracle Argus Safety
- Strong analytical, medical/scientific writing, and cross-functional communication skills
- Ability to manage multiple priorities independently in a fast-paced, resource-lean biotech environment
- Post-marketing pharmacovigilance and/or launch-readiness experience
- Experience supporting health authority inspections or internal/external audits
- Experience negotiating or managing Safety Data Exchange Agreements (SDEAs) and pharmacovigilance agreements (PVAs) with development or commercial partners
Benefits
Comp & perks- Equal employment opportunities and protection from discrimination and harassment
- Opportunity to work in a fast-paced, growing biotechnology environment
- Mentorship and guidance opportunities as part of the PV function