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Posted:
02.04.2025
Expiry Date:
17.05.2025
Job Description:
Position summary
The Executive Director, Safety Evaluation & Risk Management (SERM) Head is accountable to lead SERM (Safety Evaluation & Risk Management) medical and scientific staff and define and drive the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.
* Ability to translate strategic plans into operational plans, support guidance and deliver on medium to long term goals.
* Ability to lead and influence the development of policy and processes.
* Responsible for overseeing benefit risk management of GSK products.
* Ensures 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.
* Focuses on efficiency and effectiveness to meet the needs of our Patients and HCPs.
* Expert in representing Global Safety to key internal GSK stakeholders.
* Engages externally representing GSK Global Safety with regulators, key external stakeholders and industry forums.
* Accountable for leadership of a global group including senior staff and/or Team/Group Leaders.
Key Responsibilities
Scientific/Medical Knowledge Pharmacovigilance Expertise
* Sound judgement and decision making in safety evidence generation, benefit-risk assessment, causality assessment, evaluation of safety signals, and proactive risk management strategies.
* Coaches and mentors SERM colleagues in the scientific/medical aspects of signal evaluation methodology and risk management.
* Quality decision making and creative problem resolution in critical situations.
* Provides excellent medical/scientific judgment, strong analytical skills, proactive approach in drug safety.
* Champions/sponsors safety governance by developing safety strategy and its execution for products in clinical development and post marketing settings.
* Leads cross-GSK activities such as safety advisory panels.
* Engages in, and contributes to, broad GSK environment and pharmacovigilance environment outside GSK.
Cross-Functional Matrix Team Leadership
* Affects 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.
* Demonstrates resilience and ability to adjust behaviours and priorities based on changing environment.
* Leads or oversees SERM contribution to due diligence activities.
Communication and Influencing (internal PV Governance and External LTs)
* Leads cross-GSK activities such as safety advisory panels.
* Leads driving change until implemented.
* Influences others external to GSK to meet organisational objectives.
* Recognised as an authority with expert knowledge of relevant pharmacovigilance regulations.
Scope of Accountability
* Management of senior level colleagues and leadership of the relevant SERM Portfolios.
* Line Management and/or functional team leadership.
* Ensures compliance with applicable processes and standards.
* Accountable to lead SERM (Safety Evaluation & Risk Management) medical and scientific staff.
Candidate Profile - Qualifications & Expertise
Basic Qualifications
* Medical Doctor.
* Pharmaceutical or biotechnology industry experience.
* Clinical safety and/or pharmacovigilance experience.
* Experience with clinical development as well as post-marketing activities.
* Experience working with international pharmacovigilance requirements.
* Experience working cross-functionally.
* Direct team leadership (line management) experience.
Preferred Qualifications
* Medical or scientific post-graduate qualifications.
* Experience working in a large pharmaceutical matrix organisation.
* Understanding of related disciplines relevant to assessing safety at population level.
* Excellent communication and influencing skills.
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.
Our success absolutely depends on our people. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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