GSK
Biopharma
SERMAssociateMedicalDirector
“SERM Associate Medical Director at GSK. Skills: Medical/scientific expertise in safety evaluation and risk management, Pharmacovigilance and benefit-risk management, Signal detection and evaluation, Production of regulatory periodic reports, Safety contributions to global regulatory submissions, Advanced evaluation skills and analytical thinking, Problem identification, evaluation, and solution recommendation, Prioritization and deadline management, Facilitation of safety governance/SRTs, Buildi”
What You'll Achieve.
Ensure scientifically sound review and interpretation of data; Management of safety issues; Ensure Patient Safety globally; Meet multiple deadlines successfully; Ensure that risk-reduction strategies are implemented appropriately
Industry & Context.
Analytical thinking; Critical thinking; Ability to review, interpret and make sound medical judgments; Identify, evaluate, and recommend solutions to problems
What They're Looking For.
Must Have
Medical degree and completion of a formal postgraduate clinical training, clinical residency or specialty training, Prior experience in pharmacovigilance, drug safety, Safety Evaluation and Risk Management, benefit-risk evaluation, aggregate safety reports, clinical development and/or post-marketing activities, analytical and critical thinking skills with ability to review, interpret and make sound medical judgments based on available clinical and scientific data, organizational skills with the ability to manage multiple priorities in a fast-paced environment, Ability to learn quickly, adapt to a new process, and/or develop expertise in pharmacovigilance practices and safety regulations, Be a Team Player
Nice to Have
Familiarity with global pharmacovigilance regulations and guidelines (E. g. , ICH, FDA, EMA), Background in clinical research, epidemiology, or regulatory science, Demonstrate ability to contribute to safety strategy, risk management activities and cross-functional safety discussions, Experience working in large matrix organizations, Prior experience in the HIV therapy area is desirable but not essential
What You'll Do.
Provide medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and post-marketing settings
Ensure scientifically sound review and interpretation of data
Escalate safety issues identified through the safety review process to senior management and safety governance
Make recommendations for the further characterization
and communication of safety risks
Focus on efficiency and effectiveness to meet the needs of Patients and HCPs
Support the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally
Be responsible for signal detection and evaluation activities for assigned products
Drive production of regulatory periodic reports
Provide safety contributions to global regulatory submissions
Perform advanced evaluation skills and analytical thinking for literature review
analysis and interpretation
Make sound decisions based on relevant information or factors gathered from a broad range of sources
and recommend solutions to problems
Be committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully
Support and Facilitate safety governance/SRTs in the clinical development and post marketing settings
Assist in the establishment and operation of cross-functional teams to detect and address product safety issues
Ensure that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling
Build collaborative relationships and demonstrate good matrix leadership skills
Proactively provide input to matrix teams on safety issues and processes
Coach and mentor others
Present ideas and data clearly and concisely to a matrix team and senior staff members at the GSK Senior Governance Committees
Prepare detailed evaluations and reports on major GSK products
How You'll Work.
Team & Collaboration
Build collaborative relationships; Demonstrate good matrix leadership skills; Proactively provide input to matrix teams on safety issues and processes; Support and Facilitate safety governance/SRTs; Assist in the establishment and operation of cross-functional teams; Present ideas and data clearly and concisely to a matrix team and senior staff members
Communication Scope
Effective communication skills; Capable of presenting ideas and data clearly and concisely; Listen and respond appropriately to the views and feedback of others; Robust medical/scientific writing skills
Process & Methodology
Ability to manage multiple priorities in a fast-paced environment, Ability to prioritise activities effectively and meet multiple deadlines successfully
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