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SERM Medical Director / SERM Scientific Director
GSK. Provides in-depth medical/scientific expertise in safety evaluation and risk management of key GSK assets for complex Classic & Established Products with ongoing litigation .
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, risk assessment, and regulatory compliance in the pharmaceutical industry. Proven ability to synthesize complex safety data and lead cross-functional teams in addressing urgent safety issues.
Highest-signal resume keywords
Pharmacovigilance ExperienceRisk Management PlanningSafety Data InterpretationRegulatory Submission LeadershipMedical Doctor Qualification
ATS Keywords
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Hard Skills
Safety EvaluationRisk ManagementData AnalysisClinical DevelopmentBenefit-Risk AssessmentPharmacovigilance Data ReviewRegulatory Approval ProcessesSafety GovernanceClinical Matrix EvaluationInspection Readiness
Soft Skills
LeadershipCoachingCommunicationRelationship BuildingCross-Functional Collaboration
Certifications & Qualifications
Board CertificationSpecialist RegistrationPostgraduate Clinical Training
Industry Keywords
Pharmaceutical IndustryBiotechnologyGood Pharmacovigilance PracticesICH GuidanceCIOMS GuidanceHealth AuthoritiesSafety Review TeamsLegal DepositionsPost-Marketing ProductsClinical Matrix Organization
About the role
Key responsibilities & impact- Provides in-depth medical/scientific expertise in safety evaluation and risk management of key GSK assets for complex Classic & Established Products with ongoing litigation
- Reviews and interprets large and complex datasets
- Manages safety issues and escalates issues to senior management and safety governance as appropriate
- Recommends further characterization, management, and communication of safety risks
- Leads Pharmacovigilance and Risk Management Planning and develops strategies for evaluating issues in the clinical matrix
- Leads the safety component of global regulatory submissions
- Synthesizes, analyzes, and interprets complex safety data
- Leads safety governance and executes safety strategy for Classic & Established Products
- Anticipates, detects, and addresses product safety issues and ensures risk-reduction strategies are implemented
- Leads and facilitates Safety Review Teams and safety governance
- Leads discussions with global asset and litigation lawyers
- Leads cross-functional ad hoc teams addressing urgent product safety issues
- Escalates issues and communicates safety matters to senior governance stakeholders
- Builds working relationships and leads, coaches, and mentors others on safety issues
- Presents safety recommendations to senior GSK governance committees
- Represents GSK in safety discussions with health authorities, external consultants, partner companies, and during legal depositions
- Supports tactical and strategic changes to SERM processes and business improvements
- Maintains inspection readiness and supports audits and inspections at short notice
Requirements
What you’ll need- Relevant degree qualification
- Experience in the pharmaceutical or biotechnology industry in Pharmacovigilance, Drug Safety, Clinical Development, or a related field
- Pharmacovigilance experience in safety evaluation and risk management involving clinical-development or post-marketing products
- Knowledge of international pharmacovigilance requirements and frameworks, including ICH guidance, Good Pharmacovigilance Practices modules, or CIOMS guidance
- Knowledge of drug-development and regulatory-approval processes
- Experience working in a cross-functional matrix organization
- Medical Director pathway: Medical Doctor or equivalent physician qualification, such as MD, MBBS, MBChB, or equivalent primary medical degree
- Medical Director pathway: Completion of formal postgraduate clinical training, such as residency or recognized specialty-training program
- Medical Director pathway: Medical and scientific expertise relevant to safety evaluation and risk management in clinical-development or post-marketing settings
- Medical Director pathway: Experience applying clinical judgment to safety data, benefit-risk assessments, risk-management recommendations, or product-safety communications
- Scientific Director pathway: Health Sciences or Healthcare Professional qualification in a relevant discipline, including a bachelor’s or master’s degree in a relevant health-sciences discipline, RN, BSN, MSN, Nurse Practitioner qualification, RPh, or BPharm
- Scientific Director pathway: Scientific expertise relevant to literature evaluation, clinical-data synthesis and interpretation, safety evaluation, risk-management planning and benefit-risk assessment
- Scientific Director pathway: Experience leading and/or contributing to review and interpretation of pharmacovigilance data
- Medical Director preferred: Board certification, specialist registration, or additional relevant medical or scientific postgraduate qualification
- Scientific Director preferred: Advanced degree in a relevant health-sciences, scientific, pharmacy, nursing, or healthcare discipline (PhD, PharmD)
Benefits
Comp & perks- Annual bonus may be offered
- Eligibility to participate in a share-based long-term incentive program may be offered
- Statutory benefits provided according to Polish law
- Private medical care may be offered
- Additional paid days off may be offered
- Life insurance may be offered
- Private pension plan may be offered
- Fully paid parental leave may be offered
- Fully paid leave to care for a family member may be offered
- Hybrid working model combining office and remote work
- Inclusive recruitment adjustments available