Requirements: English
Company: Oxford Global Resources
Region: Machelen , Flanders
Ready to make an impact in patient safety? We're looking for a proactive professional to lead and maintain a compliant local PV system, ensuring alignment with global and local regulations. You'll drive performance monitoring, close compliance gaps, and help shape our local Patient Safety strategy-collaborating closely with both local and global teams.
Job description:
Implementation and maintenance of an effective local PV system for the respective affiliate(s)/country(ies) to ensure ongoing compliance with global and local legal / regulatory authority PV requirements.
Support the oversight of the local PV system and this includes consistency in process execution, monitoring of the performance of the local PV system, proactive identification of actual or potential compliance gaps, and ensuring appropriate action is taken (including escalation to local and global senior management, as applicable) to prevent or resolve compliance issues.
Development and implementation of the local Patient Safety strategy, ensuring active contribution, partnership with local and global stakeholders and impact by the team of Patient Safety Partners to the Pharma Vision
Enabling a Transparent Effective Local PV System
- As part of the broader Safety organization, support the holistic and comprehensive oversight of local PV compliance, including inspection readiness and act as deputy point of contact for Safety, internally and externally, for safety-related aspects or as deputy Qualified Person for Pharmacovigilance (QPPV), or similar, where required by the local regulatory authority. The Patient Safety Partner may be designated as the Deputy of the Patient Safety Lead within the Affiliate, or another country.
- Active contribution to the efficient, high-quality operational execution of Safety-related activities relevant to the PV system in partnership with the Pharmacovigilance Hub(s) to ensure monitoring of the safety profile of products and their safety risk management, meet regulatory requirements, and ensure license to operate. Key areas of activities in line with standard operating procedures include the following:
- Individual Case Safety Reports, Signal Detection and Management for Local Products
- Management of Aggregate Safety Reports, Pharmacovigilance Agreements, and Safety Data Exchange Agreements
- Risk Management and Safety Communication (e.g., Direct Healthcare Professional Communication, emerging safety issues)
- Studies, Programs and Other business activities with implications to patient safety and PV Compliance (e.g., interventional CT, NIS, PASS, PAES, MAP, PAA, CUP, PTAP)
- Safety Labeling and PV Commitments
- Local Pharmacovigilance System Master File (where applicable)
Note: Depending on country set-up and end-to-end process support by the PV Hub, the Patient Safety Partner may be primarily responsible, or involved in parts of operational execution of the above procedural areas, in accordance with standard operating procedures.
Support the implementation of the Safety Vigilance in the Affiliate and drive mindset and behaviours to advance PV customer centricity and value for patients.
As an active member of the local ecosystem, contribute in shaping and influencing the local safety regulatory environment driving towards safer and robust healthcare systems, working with partners such as local pharma industry associations, healthcare organizations, patient and patient groups etc.
Thought Partnership and Enablement to Advance Patient Safety Strategy
- Connect with ecosystem partners and understand the wider Affiliate priorities (e.g., Outcome Based Planning), co-create solutions and drive Safety partnership with affiliate and global functions to address customer safety needs.
- Proactive safety expert support as a thought partner for patient-centric activities and projects, including product launches, precision medicine and other strategic affiliate activities (e.g., Safety data and insights, safety risk management, adequate PV oversight on local data generation and RWE activities)
- Act as a trusted point of contact for Global Safety, the network, the Hub and be the point of contact for PJP/HSP and local colleagues for safety expertise for the assigned Disease Area or Therapeutic Area (e.g., co-create and have oversight of PV safety communication to external stakeholders including the communication of the right safety information to the right audience at the right time through the right channel in a transparent manner to address the identified and emerging needs of patients and HCPs through primary points-of-contact and channels)
- Contribute and implement the Patient Safety strategy working in close collaboration with the other functions (e.g. Medical, Access,