Pharmacovigilance Specialist Contractor (m/w/d)
The Specialist, PV is responsible for PV activities as delegated by their manager. Main focus will be:
1. 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.
2. 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.
3. May coordinate translation of PV documents and ensure a QC check is performed by a second person for any in-house translations (as applicable).
4. Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity.
5. 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).
6. Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
Depending on the PV experience of the candidate, further activities may be delegated, such as:
7. Execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned.
8. 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.
9. 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 training of local company staff, distributors, vendors, and business partners as instructed by their manager.
13. Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
14. 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).
15. 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.
16. 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.