Anant Natikar

9.5 years of experience in pharmacovigilance.

I have an experience of nine years and 10 months in Pharmacovigilance domain.

From 04 Nov 2013 to 11 Nov 2018 (total of 5 years), I have been reviewing cases, performing causality assessment and have been responsible for planning and coordination with case processing associates and quality reviewers for completion of review activities within a specified timeline and quality parameters for serious cases (Online Medical Review). During this period, I also had experience of offline medical review of non-serious cases in Pharmacovigilance domain (Offline Medical Review). I was also involved with administrative activity handling offline medical review of non-serious cases. I was also involved with process training of new joiners (onboarding training sessions).

From 12 Nov 2018 to 12 Apr 2023 (total of 4 years  4 months), I am involved with medical evaluation of Aggregate reports, Addendum statements and Annual product quality review documents and providing conclusion regarding current safety profile of the product.

From 13 Apr 2023 to present (4 months), I am working as a FTE support for client Medical Safety Leads. The work involves:
1. PSUR related activities: Providing inputs and contributors review
2. Signal evaluation and management
3. Health Authority requests: Preparation of response documents.
4. Cumulative reviews: Drafting the cumulative review.
5. RMP related activities: Providing inputs and contributors review
 

Bachelor of medicine and bachelor of surgery.