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.
Competencies
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. Makes recommendations for the further characterization, management, and communication of safety risks.
Focuses on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supports the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.
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 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.
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 developing 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.
Engages in, and contributes to, broad GSK environment and pharmacovigilance environment outside GSK with confidence, impact, integrity and professionalism.
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 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.
Communication and Influencing (internal PV Governance and External LTs)
Leads cross-GSK activities such as safety advisory panels, interfaces with and assumes ad hoc membership of a Senior Governance Committee.
Leads driving change until implemented.
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).
Recognised as an authority with expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
Scope of Accountability
Management of senior level colleagues and leadership of the relevant SERM Portfolios.
Governance body level decision-making.
Line Management and/or functional team leadership including resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.
Ensures compliance with applicable processes and standards and maintains readiness for internal audit or regulatory inspection.
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.
Candidate Profile - Qualifications & Expertise
Basic Qualifications
Medical Doctor.
Pharmaceutical or biotechnology industry experience.
Clinical safety and/or pharmacovigilance experience relating to safety evaluation and risk management.
Experience with clinical development as well as post-marketing activities.
Experience working with international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) as well as drug development and approval processes.
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 (e.g., statistics, pharmacoepidemiology).
Excellent communication (verbal, written) and influencing (internally and externally) 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 – 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).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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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