Global Clinical Safety Director

1 week ago

London, Greater London, United Kingdom GlaxoSmithKline Full time
Company Overview
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together.

About the Role
We are seeking a Senior Medical Director - SERM Senior Medical Director to join our team in Belgium-Wavre, UK. As a member of our Global Safety organization, you will be responsible for leading 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.

The Job Description:
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
- Demonstrated track record of quality decision making and creative problem resolution in critical situations, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context
- Provides excellent medical/scientific judgment, strong analytical skills, proactive approach in drug safety and high sense of urgency
- 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 and ensures that risk-reduction strategies are implemented appropriately
- Leads cross-GSK activities such as safety advisory panels, interfaces with and assumes ad hoc membership of a Senior Governance Committee
- Ability to engage in, and contribute to, broad GSK environment and pharmacovigilance environment outside GSK with confidence, impact, integrity and professionalism

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
- Proven ability to affect department, or product strategies with a strong understanding and ability to incorporate global considerations into decision making
- Builds strong collaborative relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with an outstanding track record leading a team in a matrix setting
- Demonstrates resilience and ability to adjust behaviours and priorities based on changing environment
- Leads or oversees SERM contribution to due diligence activities

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)
- Leads driving change until their implementation
- Recognised as an authority with expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities

Key Responsibilities:
- Develop and execute strategic plans for pharmacovigilance and benefit-risk management of assigned portfolio of GSK global assets to ensure Patient Safety globally.
- Provide expertise in clinical safety and pharmacovigilance activities to support the development and launch of new products.
- Collaborate with cross-functional teams to develop and implement risk management strategies to minimize harm to patients.
- Stay up-to-date with evolving pharmacovigilance regulations and guidelines, and ensure compliance with internal policies and procedures.

What You'll Need to Succeed
- Comprehensive experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, or Drug Safety.
- Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
- Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
- Experience working in large matrix organizations.

Benefits
- Competitive salary: £120,000-£180,000 per year depending on qualifications and experience.
- Opportunities for professional growth and development in a dynamic and supportive environment.
- Access to cutting-edge technology and resources to drive innovation and excellence.
- Collaborative and inclusive work culture with a focus on diversity and inclusion.

About GSK
- Uniting science, technology and talent to get ahead of disease together.
- A global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together.

Why Work at GSK?
- We believe in the power of innovation to transform lives and improve outcomes for patients.
- We're committed to creating a workplace where everyone feels welcome, valued and included.
- We offer opportunities for professional growth and development in a dynamic and supportive environment.

How to Apply
Please submit your application through our website.

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