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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 risk management. Proven leadership in guiding cross-functional teams and mentoring safety professionals within the oncology therapeutic area.
Highest-signal resume keywords
Pharmacovigilance ExperienceSafety Strategy DevelopmentRegulatory Compliance (FDA, EU, ICH)Leadership of Safety ProfessionalsClinical 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 AssessmentSafety Document Preparation (DSURs, PSURs, RMPs)Medical Case ReviewClinical Document ReviewRisk Management ActivitiesSOP DevelopmentCross-Functional Team LeadershipOncology Clinical Experience
Soft Skills
Effective CommunicationMentoringCross-Functional Relationship Building
Tools & Technologies
GPS Safety Database
Certifications & Qualifications
PharmDPhDMD
Industry Keywords
PharmacovigilanceOncologyTherapeutic AreaSafety Monitoring TeamRegulatory Agency Queries
About the role
Key responsibilities & impact- Serve as the first point of contact for all safety-related issues for assigned compounds/assets within a therapeutic area
- Represent Global Patient Safety on cross-functional strategic program teams
- Lead the safety strategy and ensure optimal support from Global Patient Safety
- Direct all Global Patient Safety activities for assigned compounds and products
- Support safety surveillance, signal management, safety-profile communication, benefit-risk assessment and responses to regulatory agency queries
- 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 partner teams
- Develop safety strategies and plans for non-compound-specific activities
- Provide medical-review support for complex ICSRs and other data sources
- Participate in developing and maintaining SOPs, working practices and guides
- Participate in continuous improvement, cross-functional relationship building and mentoring junior safety scientists
- Serve as a subject matter expert for assigned compounds
- Recommend risk-management and minimization activities
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
- Significant experience with PSURs, DSURs and (d)RMPs, or clinical development experience with demonstrated safety achievements
- 5+ years of total relevant experience in PV and/or relevant medical field with PharmD, PhD or MD degree required
- Ability to apply FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities
- Relevant clinical industry experience in oncology or the therapeutic area of interest
- 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 a GPS safety database for medical case review and simple queries
- Clinical experience and/or industry experience in Oncology is a plus
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