The opportunity
The oportunity to be responsable for performing pharmacovigilance activities within the PV Americas Operations Hub, 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 qualifications
Bachelors 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.
You Must to have advance English
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.
