As a Pharmacovigilance (PV) Senior Specialist, you will be responsible for adverse event management including aggregate and individual case safety report (ICSR) health authority submissions and compliance monitoring. You will be responsible for day-to-day case management activities for your assigned product portfolio as applicable. You will collaborate with colleagues to ensure compliance with local laws and regulations, as well as adjusting schedules to support your colleagues to ensure there is no gap in adverse event reporting and drug safety oversight.
WHAT YOU WILL DO
- Serves as the back-up Qualified Person for PV (QPPV) / Local Responsible PV person as required per local PV legislation.
- Serves as the point of contact for the local Health Authority for PV related questions from the Health Authorities (when assigned).
- Oversees all daily PV processes and activities within the countries covered by the country operation as required.
- Establishes and coordinates reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations
- Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
- Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
- Serves as SME and supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.
- Participates in and supports audits of contractual partners/vendors as necessary.
- Develops and maintains local PV-controlled documents (i.e., SOPs, CCPDs, training materials, etc. as applicable) ensuring that they are kept current.
- Assists in developing local procedures (in compliance with regional and standards) for the department, to ensure global quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
Work Experience
WHAT YOU MUST HAVE
- Degree in Life Science, medical science or health-related degree
- Demonstrated solid pharmaceutical industry experience in Pharmacovigilance/Drug Safety
- Good knowledge of PV regulations, processes and activities
- Demonstrated supervisory experience in managing people/teams/contractors
- Ability to be self-motivated and able to work with processes
- Fluent (written & oral) English communication skills with a collaborative mindset
- Ability to develop good working relationships
- Strong organisational and project management skills to handle multiple tasks under time pressure
- Proficient User of Microsoft Suite (Word, Excel)
- Experience working with safety databases such as ARGUS
