? Case intake in Pharmacovigilance Safety System (PSS) - understand adverse event report process in PV database and register accurately cases in PSS within timeline in accordance with global and regional procedures. This includes EV web download cases, MHRA cases as part of Operations team process.
? Respond to queries from country PV and/or Global PV and GPS service providers.
? Submit electronic regulatory reports (e.g., E2B files) to applicable Regulatory Authorities per procedural and regulatory requirements, as assigned.


India and South Asia PV Team, Local Pharmacovigilance Officer.

PV Quality Systems:
o To comply with the Vantive Pharmacovigilance Quality systems and policies.
o Support with audit and inspection preparation and readiness as required.
o Ensure compliance with procedures for document management retention and archiving.
o Ensure understanding of the NCR (Non-Conformance management) process. Responsible for performing NCR activities as per identified roles.
o Ensure all training requirements for the role are met.
o Ensure adherence to the BCP (Business Continuity Plan).
o With regards to third party agreements:
? Perform due diligence.
? Perform reconciliation of data between the third party and Vantive.

- Case Intake:
o Manage the receipt and capture process for adverse event (AE) and pregnancy report collection in the Pharmacovigilance safety database.
o Various activities for AEs from all sources include but are not limited to; spontaneously reported cases from patients, HCP, nurses, Vantive employees (including AEs associated with product complaints and AEs associated with medical queries), social media reports, partner companies and regulatory authorities; and solicited cases from patient support programs, market research programs, clinical studies and call centers.
o Assess the need for utilizing appropriate forms and questionnaires, complete appropriate forms and capture the information in the Pharmacovigilance safety database.
o Perform the initial assessment on case validity, check for core case elements, perform duplicate checks and request for case deletion as required.
o Perform a seriousness assessment and assess expectedness against the local label.
o Perform translation of source documents and local quality check of translation as required. Ensure all source documents are captured in the Pharmacovigilance safety database.
o Determine the requirement for follow up information and collect as much information related to a particular ICSR. Manage the process for collection and handling queries from the Global team.
o Re-assess the follow up information in the context of case validity, seriousness and expectedness; capture all follow up information and source documents in the Pharmacovigilance safety database.
o Perform ongoing tracking and local quality check of AE cases for follow up and submission requirements.
o Manage patient identified batch review requests as required.
o At adverse event case receipt, analyze for safety information that requires immediate forwarding to Drug Safety Physician.
o Perform reconciliation activities for AE’cases as required, e.g., with third parties, call centers.

- Regulatory Submissions:
o Maintain expert knowledge of the local regulatory reporting requirements.

- Safety Risk Management Activities:
o Support Pharmacovigilance Officer In charge – PvOI with Implementing risk minimization measures locally as appropriate.
o Perform surveillance activities for any new potential safety information (e.g. similar AEs reported in a cluster of reports or multiple cases for one batch received in a short time frame) and escalate as per procedures.

- Other Responsibilities:
o Update the Local Officer in charge of all pharmacovigilance activities and safety issues.



? Other duties, tasks or projects as assigned.