Elanco Innovation and Alliance Centre(IAC), (Full-Time) Sep 2021 – Apr 2023
Department: Pharmacovigilance
Position: SeniorAssociate Manager, Data Entry Team -Data Processing and Management - India
- Responsible for case intake,duplicate check, and registration of serious and non-serious adverse drug reaction cases.
- Responsible for data entryof individual case safety reportsinto the safetydatabase.
- Following up with sites regarding outstanding queries & Actionon case closureand deletion of cases
- Duplicate checkand nullification of cases.
- Ensuring adherence to requirements established by international, national, and localPV regulations and guidelines.
- Responsible for writing medically relevant safety narrativeof cases and checking the completeness and accuracy of the data entered in the various fields
- Provide technical support for department processes and maintain documentation/repositories as needed
- Maintain an awareness and be an early adopterof new technology to select the most appropriate application for a given purpose
- Responsible for coding all medical history,events, drugs indications and laboratory
tests according to the appropriate dictionary (For e.g., MedDRA,VeDDRA, Company Product Dictionary, WHO-DD).
- Ability to be able to work independently, in a flexiblemanner and adjust to change Familiarity with medical/scientific terminology
- Address medical enquires with the use of core company documents.
- Full data entry including medical coding and safety narrative
- Review data entered in safety databasefor completeness and accuracywith reference to source documents as per applicable SOPs, work instructions and client guidelines.
- Expertise in handling software’s like Argus 6.0, Argus 8.1.2, Aris G, PV entry.