14 May, 2022
Company: Global Pharma company
Should be MPharm/MBBS/ with Minimum 3-10 similar experience from reputed Generic Pharma companies only
Roles and responsibilities
Responsible for organize and maintenance of PV system (India –DCGI and US markets)
Responsible to ensure after office hours activities if required by authorities
Single point of contact for handling PV activities India –DCGI/PVPI
Pharmacovigilance officer in-charge (PvOI) for handling PV activities in India Preparation and submission of ICSRs to DCGI
Preparation and submission of PSUR/PBRER reports as per DCGI regulation
Management of RMP report includes preparation and submission as DCGI regulation ICSR Handling:
Responsible for implementing process, procedure and system for Handling ICSRs –India and US Market. Pharmacovigilance officer in-charge (PvOI) for handling PV activities in IndiaICSR activities include receipt, documentation, forwarding to team and reporting of ICSRs to DCGI/USFDA.
Tracking of ICSRs and its follow ups for additional information
Responsible for collection, processing and submission of clinical trial related cases.
Responsible for monitoring pregnancy registry, collection and processing of ICSRs.
Responsible for Monitoring Hetero website for social media cases and timely processing and submitting the ICSRs to regulatory authorities.
Responsible for review of literature articles. Process and submit valid articles to regulatory authorities as per the timelines.
Interested Pls share your updated profile to email : firstname.lastname@example.org