Description
Site Name: UK – London – New Oxford Street, Mississauga, Poznan Grunwaldzka, Warsaw Rzymowskiego 53
Posted Date: May 8, 2025
Job Purpose
Responsible to lead medical and scientific staff within the SERM (Safety Evaluation & Risk Management) and defining and driving the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.
As a senior member of the Global Safety organization the role is responsible to:
- Implement policy, processes and support the implementation of operational and strategic plans
- Ensure scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks
- Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
Key Responsibilities
Scientific/Medical Knowledge PV Expertise
- Expert in clinical safety and pharmacovigilance activities.
- Demonstrated record of sound judgement and decision making in safety evidence generation, benefit-risk assessment, causality assessment, evaluation of safety signals, and of proactive risk management strategies including management of labelling changes, physician and patient education and monitoring of safety issues in the real world.
- Coaches and mentors SERM colleagues in the [scientific/medical] aspects of signal evaluation methodology and risk management and preparation of regulatory safety reports and other documents.
Cross-functional Matrix team leadership
- Champions/sponsors safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings.
- Anticipates, detects and addresses product safety issues (e.g., product incidents) and ensures that risk-reduction strategies are implemented appropriately.
Communications (verbal, written) and Influencing (internal PV Governance and External LTs)
- Excellent communication (verbal, written) and influencing (internally and externally) skills.
- Leads cross-GSK activities such as safety advisory panels, interfaces and assumes ad hoc membership of a Senior Governance Committee. Influences others external to GSK to meet organisational objectives and may be recognised as a key player in external international pharmacovigilance activities (i.e., may be a member of trade association or external initiatives).
Why you?
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, Dentists and Veterinarians are also accepted).
- Comprehensive experience in the Pharmaceutical or Biotech industry working in Drug Safety or Pharmacovigilance
Preferred Qualifications:
- Advanced Degree
- Experience working in large matrix organisations
- Experience in Oncology
Why GSK?
Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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