Specialist, Drug Safety
hace 6 meses
The Specialist is responsible for Pharmacovigilance (PV) activities (as delegated/assigned by their manager) which may include but is not limited to PV Intake activities (including reconciliation and follow-up), Individual case safety report (ICSR) and aggregate submissions, compliance monitoring, management and negotiation of local PV agreements, local due diligence activities, supporting audits and inspections and related readiness activities, authoring local SOPs, conducting local training, and archiving and is able to perform these tasks with mínimal supervision.
Activities:
1. Serves as the point of contact for the local Health Authority for PV related questions when assigned by the PV Lead and in their absence.
2. If serving as the local QPPV / Local PV Contact / Local Responsible PV Person or Backup, complies with all requirements mentioned in the local laws and regulations.
3. Responsible for execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
4. Responsible for day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with PV procedures and country regulations.
5. Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with Corporate Policy 01: Patient Safety.
6. May coordinate translation of PV documents and ensure a QC check is performed by a second person for any in-house translations (as applicable).
7. Supports local PV audits and inspections including readiness activities and supports audits of business partners/vendors including the development of CAPAs in response to findings/observations as assigned.
8. Participates in compliance activities and coordinates the preparation of necessary corrective actions locally for late reports.
9. Assists in developing and maintaining local procedures (in compliance with regional and global standards), to ensure global quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
10. May support PV Lead in maintaining the local PV Training matrix and onboarding plans.
11. May support development and maintenance of local PV controlled documents (i.e., Company Core Pharmacovigilance Documents, training materials, etc. as applicable) ensuring that they are kept current.
12. Supports PV self-inspections as required by PV Legislations (where applicable).
13. Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity.
14. Supports training of local company staff, distributors, vendors, and business partners as instructed by their manager.
15. Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
16. May be responsible for Health Authority Website Monitoring for potential safety issues, safety alerts, and new/revised PV requirements in compliance with company procedures and local legislation (as applicable).
17. May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with business partners, vendors and Alliance Managers as required, performing local qualification/due diligence activities, compliance reviews, and ensuring maintenance of the business partner data tracking system.
18. As delegated by PV Lead, collaborates with internal stakeholders to ensure local implementation of Post approval Safety Monitoring Program (PSMP) plan in compliance with local legislation (as applicable).
19. May be responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements, as applicable.
20. As assigned by PV Lead, responsible for scheduling and coordinating submission activities for PSURs and other Aggregate Reports to the local Health Authority in compliance with company procedures and local legislation (as applicable).
21. May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations.
22. As assigned by PV Lead, prepare/maintain/submit local RMPs to the local HA (as applicable).
23. Support local implementation of applicable business continuity plans (as applicable)
24. Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
25. Serves as local Subject Matter Expert on relevant PV regulations, processes, and procedures.
26. Liaises with the local bus
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