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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance and risk management, with a strong focus on safety evaluation and regulatory compliance in clinical development. Proven ability to lead cross-functional teams and communicate complex safety data effectively to diverse stakeholders.
Highest-signal resume keywords
PharmacovigilanceSignal DetectionSafety SurveillanceRegulatory SubmissionsClinical Data Synthesis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Risk ManagementSafety EvaluationClinical DevelopmentSafety Data InterpretationRegulatory InteractionsSafety RecommendationsLiterature ReviewIntegrated Safety AnalysesDrug Development ProcessesSafety Issue Evaluation
Soft Skills
LeadershipMentoringCommunicationCollaborationJudgment
Certifications & Qualifications
Bachelor of SciencePharmDMDPhD
Industry Keywords
Pharmaceutical IndustryBiotech IndustryGlobal Pharmacovigilance RequirementsClinical MatrixProject Teams
About the role
Key responsibilities & impact- Lead pharmacovigilance activities and risk mitigation strategies for assigned oncology assets and clinical trials
- Drive evaluation and interpretation of safety data, including signal detection and assessment
- Develop strategic approaches for safety issue evaluation within clinical development programs
- Contribute to safety components of global regulatory submissions, including INDs, DSURs, and IBs
- Perform literature review, clinical data synthesis, and integrated safety analyses
- Represent Safety Evaluation & Risk Management on Clinical Matrix and Project Teams
- Lead cross-functional efforts addressing urgent and complex product safety issues
- Partner with Safety Physicians and stakeholders for Safety Review Team meetings
- Escalate emerging safety issues to senior leadership and governance bodies
- Mentor and coach junior team members as applicable
- Present safety recommendations and emerging risks to senior governance committees
- Represent GSK in interactions with regulatory authorities, external experts, and partners
- Contribute to long-term safety and clinical development strategies
- Drive continuous improvement in safety evaluation and processes
- Communicate complex scientific information to diverse audiences
Requirements
What you’ll need- Degree in a health or life sciences discipline (e.g., Bachelor of Science, PharmD, MD, PhD, or equivalent)
- 5+ years experience in pharmacovigilance, drug safety, or related safety evaluation role in the pharmaceutical or biotech industry
- Practical experience in signal detection, safety surveillance and risk management across clinical development and post-marketing
- Knowledge of global pharmacovigilance requirements and drug development processes
- Strong clinical or scientific judgement with experience interpreting clinical and safety data
- Experience in preparing regulatory safety documents and participating in regulatory interactions (preferred)
- Experience leading safety activities in a relevant therapeutic area (preferred)
- Ability to lead and influence cross-functional teams in a matrix setting (preferred)
- Experience supporting inspections, audits, and readiness activities (preferred)
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
- Remote working support
- Accommodation or other assistance to apply, if required