About the role
The Medical Office brings regulatory, medical, clinical, safety and external healthcare compliance insights and expertise to
Responsibilities- Writing, tracking, and maintaining SDEAs (Safety Data Exchange agreements) along with reconciliation and PSMFs (Pharmacovigilance System Master file).
- Be the point of contact for partners and internal stakeholders to get the agreements reviewed and finalized.
- Maintain and update SDEA tracking system, ensuring agreement obligations and responsibilities are appropriately captured in responsibility matrix.
- Serve as the primary PV contact for internal stakeholders and external business partners regarding SDEA-related matters.
- Supports in writing and maintenance of global and regional PSMFs, ensuring accuracy, completeness, and compliance with applicable regulatory requirements.
- Supports in maintenance of PSMF annexes and supporting documentation and coordinate contributions from relevant stakeholders.
- Support the organisation during PV audits and inspections, including preparation activities and management of resulting CAPAs.
- Ensure effective management of local literature surveillance and regulatory intelligence activities.
- Life sciences degree
- x Post graduate qualification
- Extensive experience in Pharmacovigilance compliance, including management of SDEAs, PSMFs, and PV training programmes.
- x Experience supporting Pharmacovigilance audits and inspections
- x Experience managing cross-functional and external stakeholder relationships.
- x Experience leading compliance and process improvement initiatives within Pharmacovigilance
- x Self-awareness, strategic mindset, results-driven, stakeholder-centric focus, team player, and willing to take accountability
- Excellent written/oral communication skills and attention to detail
- x Strong understanding of Pharmacovigilance regulations, including EU GVP, UK and regional requirements.
- Ability to work with teams across different geographies and Cultures
- x Ability to effectively demonstrate leadership in a team environment, which requires negotiation, persuasion, collaboration, and analytical judgment
- x Innovative solution finding
- x Strategy setting and implementation
- x Self-starter with a drive and perseverance to achieve result
- x Ability to work with teams across different geographies and Cultures
- x Proficient in time and project management skills