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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 signal detection, risk management, and regulatory compliance. Proven ability to lead cross-functional teams and communicate complex safety data effectively to diverse stakeholders.
Highest-signal resume keywords
PharmacovigilanceSignal DetectionRegulatory SubmissionsRisk ManagementClinical Development
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 Data EvaluationSafety SurveillanceClinical Data SynthesisIntegrated Safety AnalysisRegulatory Safety Document PreparationDrug Development ProcessesSafety Issue EvaluationEmerging Risk AssessmentLiterature ReviewCross-Functional Team Leadership
Soft Skills
MentoringCommunicationScientific JudgmentInfluencingCollaboration
Certifications & Qualifications
Advanced Degree in Health or Life Sciences
Industry Keywords
OncologyPharmaceutical IndustryBiotech IndustryGlobal Pharmacovigilance RequirementsPost-Marketing SafetyClinical MatrixGovernance BodiesSafety Review TeamRegulatory AuthoritiesSafety Evaluation Processes
About the role
Key responsibilities & impact- Lead pharmacovigilance activities and risk mitigation strategies for assigned oncology assets and clinical trials
- Evaluate and interpret 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 reviews, clinical data synthesis, and integrated safety analyses
- Represent SERM 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)
- Extensive experience in pharmacovigilance, drug safety, or related safety evaluation 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 judgment with experience interpreting clinical and safety data
- Advanced degree or equivalent clinical qualification preferred
- 10 or more years of pharmacovigilance or medical safety experience preferred
- Experience 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 may be offered
- Eligibility to participate in a share-based long-term incentive program, dependent on role level
- Benefits package details supplied during the recruitment process
- Agile working culture and flexibility opportunities
- Equal opportunity employment
- Process adjustments available for applicants who require them