PV Specialist
2 meses atrás
At Organón, we are seeking a highly skilled PV Specialist to join our team.
Responsibilities
- Manage and track adverse event cases in accordance with global pharmacovigilance procedures and country regulations.
- Process individual case safety reports (ICSRs) and perform reconciliation activities.
- Execute local PV processes and activities in alignment with PV systems and quality management systems.
- Support Patient Support Programs and/or Market Research vendor(s) related activities.
- File, store, and archive safety-related and regulatory data and documentation.
- Act in full compliance with global and local SOPs and report any deviations or compliance concerns.
Requirements
- A minimum of 1 year of industry experience in pharmacovigilance and/or regulatory affairs.
- A general knowledge of PV regulations within the assigned country.
- Excellent communication and time management skills.
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