SERM Medical Director - Vaccines

Job content

Site Name: Belgium-Wavre, Amsterdam, GSK House, Rockville Vaccines, Siena

Posted Date: May 2 2023

Safety Evaluation and Risk Management (SERM) Medical Director

The role will be based at our site in Belgium

Global Clinical Safety & Pharmacovigilance is responsible for the collection, processing and

regulatory reporting of adverse events experienced by patients receiving GSK products and for the

ongoing safety evaluation and risk management of all GSK products (marketed or developmental).

You will be accountable for the product team level GSK asset Benefit Risk profile and Benefit Risk management. You will provide in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting. Ensure 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. Make recommendations for the further characterization, management, and communication of safety risks.

You will focus on efficiency and effectiveness to meet the needs of our patients and HCPs, supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally.

Detailed Description Of The Role

Scientific/Medical Knowledge PV Expertise

• Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.
• Leads the safety component of global regulatory submissions.
• Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.
• Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.
• Shows a high level of commitment and passion about their role. Demonstrates highly-developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.
• Explores positions and alternatives to reach mutually beneficial agreements and solutions.
  
  

Cross-functional Matrix team leadership

• Leads 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.
• Leads cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency.
• Accountable for the escalation of issues and communication on safety matters (e.g., QPPV, safety boards, other governance boards and committees, etc).
• Builds strong working relationships and displays excellent leadership skills on safety issues whilst working in a matrix team, with a demonstrated ability to lead a team in a matrix setting.
• Represents Global Safety on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad-hoc teams to address urgent and important product safety issues.
• Facilitates safety governance/Safety Review Teams in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.
• Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.
  
  

Communications (verbal, written) and Influencing (internal PV Governance and External LTs)

• Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees. Has the skillset to interact with confidence, credibility, and influence at all levels of the GSK organisation. In addition, is expected to represent GSK and contribute to safety related discussions at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
• Leads cross-functional process improvement team within GSK.
• Thinks tactically/strategically and takes account of the internal and external environment when considering safety issues and changes to SERM processes or business improvements. Contributes to development of long-term strategy for clinical programs.
• Regularly contributes innovative ideas to address new issues or improve approaches to existing operations.
• Leads inspection readiness and prepared as needed to support audits/inspections.
  
  

Why you?

Basic qualifications and skills:

• Medical Degree, specialisation preferred (Board Certified or Eligible) with clinical practice experience
• Experience in a pharma/biotech or regulatory agency required in a relevant function such as clinical safety or pharmacovigilance
• Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities
• Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education. Likely to be recognised as an authority in this area at high levels within GSK outside of Clinical Safety and Pharmacovigilance and possibly in the external international pharmacovigilance arena
• In depth knowledge of medical and drug terminology and a sound foundation in pharmacology.
  
  

Preferred qualifications and skills:

• Prior experience in Internal Medicine, Infectious Diseases, Hepatology
• Prior experience contributing to NDAs, BLAs, sNDA, and/or MAAs
• Prior experience of working in biologics such as vaccines and mono-clonal antibodies would be advantageous
  
  

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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 positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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