Pharmacovigilance Specialist
1 semana atrás
**Job Summary:**
We are seeking a highly skilled Pharmacovigilance Specialist to join our team at Organon. As a key member of our Global Safety Department, you will be responsible for the day-to-day management of adverse event case reports.
Responsibilities:
- Manage and coordinate adverse event case intake and follow-up activities in accordance with global pharmacovigilance procedures and country regulations.
- Perform case safety report (ICSR) tracking, translation to English, and forwarding of information to the Data Management Center.
- Execute local pharmacovigilance processes and activities in alignment with PV systems and their associated Quality Management System.
- Reconcile adverse event cases received from local operating units and contractual partners, and process reports in accordance with local procedures and PV legislations.
Requirements:
- Minimum 1 year of industry experience in pharmacovigilance and/or regulatory affairs.
- General knowledge of PV regulations within assigned countries and expertise in PV processes/activities.
- Good communication and time management skills.
- Health, life science, or medical science degree or equivalent by education/experience, and fluency in English (written and spoken).
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