praveena nair

Senior Associate with 5 years of experience in the area of human and animal -pharmacovigilance in pharmaceutical industry.

• Document and process adverse event information from solicited, study and spontaneous reports including basic case entry for all pharmacovigilance cases
• Ensure data accuracy, follow-up and reconciliation is completed on pharmacovigilance cases
• Prepare and conduct productspecific trainings.
• Review patient information in database and ensure accurate documentation as per client needs
• Quality Review and evaluateAE case information to determinerequired action based on and Following internal policies and procedures.
• Support audit & inspections.
• Expertise in safety surveillance areas like adverseevent reporting, periodicsafety reporting, signal detection and risk minimization.
• Expertise in handling software’s like Argus 6.0, Argus 8.1.2,PV entry, Aris G, PV works.
• Advanced Excel: Lookup functions, matching functions, pivot tables, formulas, conditional formatting.

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.