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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, safety strategy development, and regulatory compliance, with a strong focus on safety surveillance and signal management. Proven leadership in guiding cross-functional teams and mentoring safety professionals in a clinical or pharmaceutical environment.
Highest-signal resume keywords
Pharmacovigilance ExperienceSafety Strategy DevelopmentRegulatory ComplianceTeam LeadershipClinical Development Experience
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 ManagementBenefit-Risk AssessmentDSURs PreparationPSURs PreparationRMPs DevelopmentClinical Document ReviewFDA Guidelines ApplicationICH Guidelines ApplicationOncology Experience
Soft Skills
Effective CommunicationCritical AnalysisCross-Functional CollaborationMentoringContinuous Improvement
Tools & Technologies
GPS Safety Database
Certifications & Qualifications
PharmDPhDMD
Industry Keywords
PharmacovigilanceClinical TrialsPost-Marketing SurveillanceSafety Monitoring TeamTherapeutic Area Experience
About the role
Key responsibilities & impact- Serve as the first point of contact for all safety-related issues for assigned compounds/assets
- Lead safety strategy and ensure optimal support from Global Patient Safety
- Represent Global Patient Safety on cross-functional strategic program teams
- Direct all Global Patient Safety activities for assigned compounds and products
- Support safety surveillance, signal management, safety-profile communication, benefit-risk assessment and regulatory responses
- Prepare and review safety documents including DSURs, PSURs, development RMPs and RMPs
- Review clinical documents including Investigator Brochures, protocols and clinical study reports
- Lead cross-functional Safety Monitoring Team activities
- Represent Global Patient Safety on RSOC, IDMC, SPT and external stakeholder teams
- Develop safety strategies and planning for non-compound-specific activities
- Act as a medical-review resource for complex ICSRs and other data sources
- Participate in SOP, working-practice and guide development and maintenance
- Drive continuous improvement, cultivate cross-functional relationships and mentor junior safety scientists
Requirements
What you’ll need- Minimum 10+ years of total relevant experience in PV and/or relevant medical field or equivalent industry experience in drug safety, including significant experience with PSURs, DSURs and (d) RMPs; or clinical development experience with demonstrated achievements in safety
- 5+ years of total relevant experience in PV and/or relevant medical field with PharmD, PhD or MD degree required
- Clinical experience and/or industry experience in Oncology is a plus
- Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities in clinical trial and post-marketing environments
- Relevant clinical industry experience in the therapeutic area
- Proven ability to lead and develop a diverse team of Safety Professionals
- Ability to work across organizational levels and communicate safety viewpoints and findings effectively
- Ability to utilize GPS safety database for medical case review and simple queries
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process where required