Executive Director, Serm Head - Vaccines Siena

Executive Director, Serm Head - Vaccines
Siena
Toscana, Siena

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.

Responsible for overseeing benefit risk management of GSK products.

Ensures scientifically sound review and interpretation of data and management of safety issues.

Makes recommendations for the further characterization, management, and communication of safety risks.

Supports the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets.

Expert in representing Global Safety to key internal GSK stakeholders.

Engages externally representing GSK Global Safety with regulators and key external stakeholders.

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.

Provides excellent medical/scientific judgment and strong analytical skills.

Champions/sponsors safety governance by developing safety strategy and its execution.

Leads cross-GSK activities such as safety advisory panels.

Cross-Functional Matrix Team Leadership Affects department or product strategies with a strong understanding of global considerations.

Builds strong collaborative relationships and displays excellent leadership skills.

Leads or oversees SERM contribution to due diligence activities.

Communication and Influencing Leads cross-GSK activities such as safety advisory panels.

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.

Ensures compliance with applicable processes and standards.

Candidate Profile - Qualifications & Expertise Basic Qualifications Medical Doctor.

Pharmaceutical or biotechnology industry experience.

Clinical safety and/or pharmacovigilance experience.

Experience with clinical development and post-marketing activities.

Direct team leadership experience.

Preferred Qualifications Medical or scientific post-graduate qualifications.

Experience working in a large pharmaceutical matrix organisation.

Excellent communication and influencing skills.

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease 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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