Head Medical Governance and Pharmacovigilance (m/f/d)
Posted Date: Sep 6 2024
We are seeking an experienced and committed individual to lead our Medical Governance team and carry out all pharmacovigilance activities under local responsibility.
This role combines leadership skills with specialized knowledge in the areas of pharmacovigilance and medical governance, making it a unique and challenging opportunity.
The successful candidate will be a member of the Medical Leadership team and will report directly to the Country Medical Director. This position will involve significant cross-functional interactions with stakeholders in both commercial and medical departments, requiring excellent collaboration and communication skills.
Key Responsibilities
- Lead a team of Medical Governance Managers and Scientific Advisors responsible for the completion of certification of promotional and non-promotional materials, management monitoring, risk management and handling of Article 71 requests.
- Act as as Named Safety Contact for Switzerland with overall responsibility for the day-to-day management of pharmacovigilance activities for marketed products and products in clinical trials, including all Pharma products, Vaccines and ViiV products the Swiss Local Operating Company (LOC) is accountable for.
- Represent GSK Switzerland in all drug safety related aspects towards local authorities and legal bodies in cooperation with the Country Medical Director.
- Ensure the LOC is prepared for internal audits and Authority inspections (related to the Pharmacovigilance activities), providing support and advice as required.
- Support Medical Department in embedding Governance and provide guidance to internal stakeholders, to enable them to set the framework for local activities aligned with global processes and Swiss regulations.
- Assess and approve medical projects/activities.
Qualifications & Skills
- Advanced degree in medical or life science field
- Extensive experience in leading teams and working in cross-functional setting.
- Experience within drug safety environment and certification of materials with in-depth and hands-on knowledge.
- Strong knowledge of Swiss regulations and standards.
- Exceptional communication and interpersonal skills, with the ability to effectively interact with cross-functional stakeholders.
- Ability to manage multiple tasks simultaneously with strong commitment to accuracy.
Additional Requirements:
- Language Proficiency: Must be fluent in both German and English. Proficiency in French or Italian is a significant plus.
- Education: Must possess at least a Master’s degree in Medicine or Life Sciences
- Technical Skills: Advanced knowledge of MS Office Suite (Word, Excel, PowerPoint, Outlook) and Pharmacovigilance database (preferably Argus) is essential.
This role offers a fantastic opportunity to lead a motivated team to ensure respect of GSK procedures and local regulations, while taking responsibility for the day-to-day aspects of pharmacovigilance and make a significant impact on patients’ outcomes and safety.
If you are a team-oriented, proactive individual with passion for science and medicine, we would love to hear from you.
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