Vice President, Head of Pharmacovigilance Operations, Open to flexible working
The Head of Pharmacovigilance Operations leads a team of approximately 100 within the assigned Global Safety teams and oversees both strategic and day-to-day perspectives of pharmacovigilance operations including but not limited to:
- Case Processing: all activities linked directly or indirectly to the case processing
- SDEA: all activities related to the set-up, maintenance and oversight of safety data exchange agreements with third parties
- MAPS: all activities related to the central oversight of MI/PV activities organized in the hub-model maintained by an outsourcing partner
- Literature: all activities related to identification of ICSRs and articles of interest in published literature
The role reports directly to the Senior Vice President, Clinical Safety & Pharmacovigilance and may be based at either GSK House, Brentford, London, UK or Wavre, Belgium.
- Oversight of processes to ensure organisation, efficient outsourcing, communication and tracking of case processing and related activities and performance, including generation and reporting of metrics to appropriately manage business risks, and to enable senior management to monitor the compliance and the success of the pharmacovigilance (PV) operating model.
- Leads and drives the implementation of the pharmacovigilance strategy to ensure compliance with all relevant central GSK and outsourcing partner activities, including conduct of relevant monitoring activities and to mitigate business risk related to case processing activities and safety data exchange activities.
- Responding to changes in the regulatory framework for PV operations.
- Driving improvements for the operational aspects of PV as part of the digital and data-analytics agenda.
- Accountable for setting up and maintaining an efficient set up of key performance indicators for the pharmacovigilance operations activities.
- Oversight of work done across a global matrix environment for Safety Data Exchange (SDE) matters (CMGs, SERMs, Clinical Operations, Regulatory, Compliance, local operating companies and licensing partners). This includes diligent follow-up on actions for internal stakeholders and external partners. This is to ensure that GSK can meet its Pharmacovigilance obligations world-wide.
- Oversight of Medical Information and PV-intake activities done by third party providers on behalf of local operating companies.
- Oversight and close cooperation with PV-systems ensuring optimal system management for PV-related systems (i.e. ARGUS and related systems).
- Support of GxP related audits and inspections including follow-up activities for corrective and preventive actions (CAPA).
- Responsible for ensuring adverse event documentation and follow-up processes are in compliance with legal and regulatory statutes for all marketed products.
- Being member of the Central Safety Department (CSD) LT, defining the strategic direction of CSD.
- Participate and attend all relevant meetings/educational seminars to ensure that knowledge of pertinent medical or Pharmacovigilance issues are up to date.
Due to the universal application of safety-related activities at all levels of discovery, development and life cycle management, and the impact on overall portfolio, sales and growth of GSK, the role requires an advanced analytical and problem-solving mindset to:
- Interface across the R&D, Commercial Strategy, and Regulatory matrix environment.
- Understand the full breadth and scope of the product pipeline in development and products in the market.
- Network with peers who lead other departments concerning safety-related matters.
- Partner with Safety Heads of respective therapeutic areas, QPPV and other senior leaders in CSD.
- MSc in Biomedical Sciences or similar academic standard/background.
- 10-12 (+) years of increasing experience in the Pharmaceutical or Biotech industry working in Clinical Development, Pharmacovigilance Operations, Drug Safety or a related field.
- Must have an in-depth understanding of FDA, EMA and other Health Agency regulations regarding pharmacovigilance activities.
- Additional experience in Pharmaceutical Medicine (Drug Discovery, Drug Development, Medical Affairs, Medical Information) is an asset.
- Essential to be an effective team member and strong leader in a cross-functional department.
- Very strong communication and influencing skills.
- Strategic and innovative thinking.
- Strong analytical skills.
- Proven track record in capability building in Drug Safety, Risk Management / PV.
- Rigorous and well organised.
- Proficient in prioritising assignments and able to adapt to rapidly changing priorities.
- Extensive experience in proactive risk assessment, ad hoc crisis management, monitoring of operational safety issues, and solution-oriented approach to crisis issues under pressure.
- Outstanding change management capabilities.
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.
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