Highlights:I am a Pharmaceutical Physician and having Master degree in Pharmaceutical Medicine. I am well versed in Pharmacology, Clinical Medicine, Pharmacovigilance, Clinical and Preclinical studies, Drug regulation and various guidelines like ICH, CIOMS,CFR, FDA etc. I am having four years of professional experience in field of Pharmacovigilance and Clinical Research.

Skills:Pharmacovigilance, Drug Safety and Medical writing

Goal:Pursuing a challenging career in Pharmacovigilance and Medical writing.

Certification:Master in Pharmaceutical Medicine qualified with 64% Bachelor in Homoeopathic Medicine and Surgery qualified with 64% Certification in Pharmacovigilance qualified with A grade

Honor:I got distinction in two subject in my PG examination, Drug discovery, development and Drug Safety, Pharmacovigilance

Drug Safety Specialist 09/2013 - current
Cognizant Technology Solution, Mumbai, Maharashtra India
Industry: Pharmaceutical (Pharmacoviiglance Drug Safety)
I am working as Drug Safety Specialist and working as key team player, mentor and as subject matter expert
My roles and responsibilities- -Working as key team player and performing various activities like case allocation, case prioritization as per the regulatory and partner timelines and timely completion of work log and query resolution of the team members. -Pharmacovigilance case processing according to the various regulation, guidelines, SOPs and project requirement using the database like “Argus”. -Raising the queries to the safety affiliate for missing information in ADR form. -Assessing the listedness of the adverse event using CDS, IB, SPC and USPI. -Quality review of the case and providing timely feedback to the case processors -As mentor, training new team members on safety data processing and project related activities -Perform all supporting activities as assigned e.g. preparation of defect tracker, query tracker etc--
Drug Safety Associate 04/2012 - 09/2013
Sciformix Tech Pvt Ltd, Pune, Maharashtra India
Industry: Pharmaceutical (Pharmacoviiglance Drug Safety)
I worked as Mentor and SME in my team
My roles and responsibilities- -Receive information on adverse events, perform initial checks, identify duplicate/invalid cases and process appropriate follow-up to the initial cases received, create case file and initialize, complete all entry from received drug safety reports in the safety database. -Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source document with emphasis on timeliness and quality. -Ensuring the coding of adverse events/indication/Patient History/lab Data by MedDRA dictionary (ver. 16.1) -Ensuring the coding of products with CDD and WHO drug dictionary. -Reconciliation of data on daily & monthly basis. -Documenting the observations on an internal generated Quality check sheets (defect tracker, quality control monitoring sheet, query tracker).--
Clinical Study Coordinator 06/201 - 04/2012
Max Neeman International, Pune, Maharashtra India
Industry: Pharmaceutical (Clinical Research)
I worked in Clinical trial site management
-Assist in generating follow up report of the SAE. -Data entry of the patient trial data into the client data base. -Screening and recruitment of subjects as per protocol. -Informed consent process, Drug dispensing. -Ethics committee correspondence. -Coordinating all the activities related to the conduct of the clinical trials.--

Maharashtra University of Health Science 01/2001 - 01/2006
Pune, Maharashtra, India
Degree: Bachelor's Degree
Major:Bachelor in Homoeopathic Medicine and Surgery
Bachelor in Homoeopathic Medicine and Surgery is four and half year full time course conducted by Health Science University. I studied Anatomy, Physiology, Pathology, Clinical Medicine, Pharmacology, Surgery etc

Dr Vijay Nagarkar MS Pharm Med Drug Safety, Pharmacovigilance, Medical writing