Vikalp Patre

Previously, I have work experience In Formulation and Development Department as a Research Associate in Lok-Beta pharmaceutical.Having more than 2 year's of experience.

Handling Different

Dosage forms(Tablet, Powder sachet,cream etc). Recently, I have worked for TCS in the Regulatory information management system (RIMS). Submition of license to EMA through XEVMPD Article (2) database. I that I worked for New creation, Invalidation, Variation updation in XEVMPD. also IDMP Releted work.

Veeva

Vault and Liquent InSight. Currently I am working with Syneos Health for EMA xEVMPD validation. Additionally SPOR, Service now requests, 3rd Acknowledgement query. PMS activity.

Safety and PV Specialist-1 at Syneos Health (2022-05 – Present)

• Working on xEVMPD database for EMA validation
• Validation of New, Update entries in database.
• Worked on Different tools like DMTT, HMA, EDQM, WHO-ATC, and MedDRA etc.
• Give response to MAH on 3rd ACK and service now desk tickets.

Senior Regulatory Affairs Associate at Tata Consultancy Services (TCS) (2019-11 – 2022-05)

Working in Regulatory Information Management System. Knowledge of Various Database like xEVMPD, PRION, OPAL, Veeva Vault, Power Bi etc. Knowledge of ICH Guidelines Knowledge of various clinical guidelines and sops. Submitting Variables/ Labeling of Product information in database to EMA. Maintaining IDMP datasheet.

Research Associate at J. Duncan Healthcare Pvt. Ltd, a Concern group of Lok Beta Pharmaceuticals (2017-01 – 2019-11)

• Worked mainly in product development department.
• Handled formulations like Tablet, capsule etc. sound knowledge of different documents like PDR, Techmar, BMR etc.

M.Pharma in Pharmacy – Nagpur University Department of Pharmaceutical Sciences, Nagpur (2016)

B.Pharma in Pharmacy – Government College of Pharmacy Aurangabad (2014)

12th in English – Maharashtra (2008)

10th in Marathi – Maharashtra (2006)