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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 risk management, with a strong focus on safety evaluation, regulatory submissions, and cross-functional leadership. Proven ability to synthesize clinical data, implement risk-reduction strategies, and coach teams in a matrix organization.
Highest-signal resume keywords
Pharmacovigilance ExperienceSafety EvaluationRisk ManagementSignal DetectionRegulatory Submissions
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Safety EvaluationRisk ManagementSignal DetectionSafety SurveillanceClinical Data AnalysisRegulatory AdherenceSOP DevelopmentProcess ImprovementDrug Development KnowledgeInternational Pharmacovigilance Requirements
Soft Skills
Excellent Communication SkillsInfluencing SkillsTeam LeadershipCoachingMentoring
Certifications & Qualifications
PharmDPhDBachelor of Science in Life SciencesBachelor of Science in Medical Sciences
Industry Keywords
Pharmaceutical IndustryBiotech IndustryClinical DevelopmentPost-Marketing ActivitiesICHGVP ModulesCIOMS InitiativesMatrix Organizations
About the role
Key responsibilities & impact- Provide in-depth medical/scientific expertise in safety evaluation and risk management of GSK assets
- Support pharmacovigilance and benefit-risk management for assigned global assets
- Lead pharmacovigilance and risk-management planning and develop evaluation strategies
- Lead the safety component of global regulatory submissions
- Review literature and synthesize, analyze, and interpret clinical data
- Lead safety governance and execute safety strategies for products in clinical development and post-marketing settings
- Anticipate, detect, and address product safety issues and implement risk-reduction strategies
- Facilitate safety governance and safety review teams
- Represent GSK on cross-functional Clinical Matrix and Project Teams
- Lead cross-functional teams addressing urgent product safety issues
- Lead or participate in process initiatives and workstreams improving regulatory adherence, data standards, quality, and efficiency
- Author or participate in SOP and standard updates
- Escalate issues and communicate safety matters to governance bodies
- Present safety recommendations and issues to senior GSK governance committees and external stakeholders
- Lead cross-functional process improvement teams
- Contribute to long-term clinical program strategy and operational improvements
- Lead inspection readiness and support audits and inspections
- Coach and mentor colleagues
Requirements
What you’ll need- PharmD/PhD for Scientist preferred; Bachelor of Science in Life Sciences or Medical Sciences minimum standard
- 5+ years of experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance or Drug Safety
- Significant pharmacovigilance experience in Safety Evaluation and Risk Management, including clinical development and post-marketing activities
- Experience with Signal Detection and safety surveillance
- Knowledge/experience of international pharmacovigilance requirements, including ICH, GVP modules, and CIOMS initiatives
- Knowledge/experience of drug development and approval processes
- Experience working in large matrix organizations
- Excellent verbal and written communication and influencing skills
- Ability to lead teams in a matrix setting
- Ability to coach and mentor others
Benefits
Comp & perks- Annual bonus
- Eligibility to participate in share-based long-term incentive program
- Health care and other insurance benefits for employee and family
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave
- Comprehensive US employee benefits program