Vaccines SERM Head

Role summary

The Safety Evaluation & Risk Management (SERM) Head leads a global team of physicians and scientists overseeing the clinical safety and pharmacovigilance activities for a group of assets in the Vaccines portfolio. The role reports to the Vice President and Head of Vaccines Safety.

The SERM Head is accountable for the global leadership of safety evaluation and risk management strategies of key GSK assets or other highly complex products in clinical development and/or the post-marketing setting, in alignment with business strategies. The SERM Head is a member of the Vaccines Safety Leadership Team and may deputize for the Head of Vaccines Safety.

Responsibilities

• Ensures top quality safety input into clinical development planning activities, safety evidence generation, benefit-risk assessments, and global and regional risk management plans for designated products.
• Coordinates medical and scientific SERM resources to Vaccine projects, process initiatives and Due Diligence activities, providing adequate management and ensuring development of SERM staff.
• Oversees the signal detection and evaluation process for products within the SERM team portfolio.
• 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.
• Assists teams for presentations to Global Safety Board and other R&D governance forums.
• Ensures compliance with applicable processes and standards and maintains readiness for internal audit or regulatory inspection.
• Trains, coaches and mentors SERM staff in scientific aspects of pharmacovigilance and risk management and builds SERM capabilities.
• May lead cross-functional ad hoc teams to address urgent and important product safety issues.
• Reviews and provides technical approval for investigator brochures, protocols, informed consents, final study reports and external data monitoring committee charters.
• Safety representative for Protocol Review Board.
• May chair or be a member of an internal Safety Review Committee (iSRC) or firewall team.

• Builds collaborative relationships with internal peers and cross-functional stakeholders, and external network, to drive upper quartile performance.
• May present the disease area or product area safety strategy at key internal GSK meetings, and represent GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.

• May participate in, or lead, cross-GSK activities such as safety advisory panels, task forces or scientific forums.

Education, Knowledge and Technical Experience

• Medical doctor, pharmacist or PhD with knowledge of infectious diseases, epidemiology and biologicals.
• Minimum of 6 years experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance / Drug Safety or a related field (e.g., Medical Affairs, Clinical Science) with solid understanding of, and sound capabilities in, SERM activities including:
  • Global safety-related regulations and regulatory expectations.
  • Benefit-risk assessment.
  • Design of clinical development and post marketing safety activities to ensure that human safety is being addressed proactively throughout a product life cycle.
  • Scientific concepts and methodologies applicable to safety risk identification and characterization, such as causality assessment, aggregate data analysis and design of proactive risk management strategies.
  • Related disciplines (e.g., statistics, pharmacoepidemiology) relevant to assessing safety at the population level.

Behavioural Competencies

• 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.
• Excellent leadership in matrix team setting.
• Proven ability to coach and develop staff.
• Ability to manage and co-ordinate tasks, projects, and processes across organisation in complex and critical situations.
• Highly effective communication skills; able to present complex data to groups at all levels of the organisation and externally to GSK.
• Highly developed negotiating and influencing skills.
• Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality.
• Aptitude in contributing innovative ideas to address new issues or improve approaches to existing operations with demonstrated ability to take a lead in driving needed change.
• Ability to adjust behaviours and priorities based on changing environment.
• Demonstrated ability to think tactically and strategically and take account of internal/external environment when considering safety issues and business processes.
• Ability to engage in, and contribute to, broad GSK environment and pharmacovigilance environment outside GSK with confidence, impact, integrity, and professionalism.

Why GSK

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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