Safety, Evaluation & Risk Management (SERM) Associate Medical Director, Safety Physician Vaccines
Location: Wavre, Belgium; Siena, Italy; Poznan, Poland; London, United Kingdom
Department: Medical and Clinical
Job ID: 409226
Job Type: Full Time
Job Purpose:
Provide medical and scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or post-marketing settings. Ensure scientifically sound review and interpretation of data, escalate safety issues when necessary, and recommend further characterization, management, and communication of safety risks. Focus on efficiency and effectiveness to meet the needs of Patients and Healthcare Providers globally.
Responsibilities:
Scientific/Medical Knowledge and PV Expertise:
Responsible for signal detection and evaluation activities for assigned products.
Drive production of regulatory periodic reports, RMPs, and associated documentation globally.
Author SERM safety contributions for global regulatory submissions in partnership with the product physician.
Respond to auditor/inspector requests and complete CAPAs within agreed timelines.
Apply advanced evaluation skills for literature review, data gathering, synthesis, analysis, and interpretation.
Make sound decisions based on a broad range of relevant information and factors.
Cross-functional Matrix Team Leadership:
Support and facilitate safety governance/SRTs for clinical development and post-marketing safety.
Lead or participate in cross-functional initiatives to improve adherence to regulations, quality, and efficiency.
Author or contribute to updates of standard operating procedures (SOPs).
Build strong collaborative relationships and demonstrate matrix leadership, providing proactive input on safety issues.
Coach and mentor others within the matrix team.
Communication and Influencing:
Present complex issues to GSK Senior Governance Committees.
Contribute ideas proactively to improve operations and processes.
Participate in process improvement initiatives within GCSP.
Prepare detailed evaluations and reports with robust medical/scientific writing skills.
Use effective negotiation, influencing, and persuasion skills within matrix environments.
Required Qualifications:
Medical Doctor (physician) degree.
Substantial experience in pharmacovigilance or drug development.
Experience in Safety Evaluation and Risk Management across clinical and post-marketing settings.
Knowledge of international pharmacovigilance requirements (ICH, GVP modules, CIOMS initiatives).
Experience working in large matrix organizations.
Why GSK?
GSK unites science, technology, and talent to get ahead of disease together. We are a global biopharma company with a special purpose: to positively impact the health of billions and deliver sustainable returns for shareholders. We focus on vaccines, specialty and general medicines, investing in infectious diseases, HIV, respiratory/immunology, and oncology. GSK is committed to creating an inclusive, inspiring workplace where people feel valued and can grow professionally.
Note: GSK does not accept referrals from employment businesses or agencies without prior written authorization.
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