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Pharmacovigilance Associate
hace 4 meses
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.The opportunity
The opportunity to be Core member of the safety team and responsible for performing pharmacovigilance activities within the North America PhV unit, in partnership with the Drug Safety Specialists/Pharmacovigilance Safety Specialists and Pharmacovigilance Managers/Director to receive and review adverse event information for pre and post- marketed products.
Your experience and qualificationsBachelors of Science (Physics, Chemistry, Biology, Biochemistry, microbiology, physiology, anatomy, pharmacology).
3-5 years Global experience of Pharmaceutical industry or CRO experience and at least 2 years of Pharmacovigilance experience following up processes.
Demonstrates proficiency with Microsoft Office Word, Excel, PowerPoint and Adobe Acrobat. Knowledge of PhV IT systems such as Arisg, Argus, Cognos is an added advantage.
Activities:
Responsible for triaging of adverse event information , including extraction, upload and triage of XMLs.
- Performs case registration of adverse event reports by entering searchable information and performing duplication checks.
- Responsible for sending adverse event information to in license partners within the required timeline as per pharmacovigilance agreement.
- Responsible for collecting additional information from reporters and performing follow-up with health care professionals and consumers.
- Review and assessment of reportability of the adverse event to FDA/Health Canada as applicable.
- Responsible for receiving, reviewing and performing all necessary actions pertaining to negative acknowledgements for FDA and Health Canada as applicable.
Manager Pharmacovigilance in US
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