Pratik Rawate
Regulatory Affairs_Immediate Joiner\\nVeeva Valut | RIM | IDM D2| ISI Toolbox | Liquent Insight Publisher | Adobe Acrobat | Submission | Publisher \\nExpertise in Regulatory Affairs with a master\'s in pharmaceutics
- Role
- Publishing Associate at Tata Consultancy Services
- Location
- Thane, IN
- LinkedIn followers
- 500 followers
About Pratik Rawate
Serving as a Regulatory Affairs Associate from Dec 2021 to till date. Having expertise in handling, formatting different types of clinical, non clinical, drug safety reports such DSUR, PBRER, PADER, SSR, NSR, Annex, ACO, Clinical overview reports etc. Expertise in different regulatory publishing tools such as Veva vault, IDM D2, LIQUINT Insight Publisher, ISI Toolbox, Smart-links etc With skills like- Team player Good Listener Quick learner Good communication skills Interpersonal skills Ability to work within a tight timeline Good management and presentation skills.
Experience
Publishing Associate
Dec 2022 — Present · Thane, IN
Compliance check of different clinical and non clinicaldocuments. Including Protocols, Investigators brochure,clinical other documents and Drug safety reports.• Publishing ofGranular and merging CSR using insight publisher.• Performing 1st QA for published documents.•Compliance check and logic check of product annexes(Information labels and leaflets).• Publishing of literature reference, SmPC documentsExpertise in regulatory documents formatting, bookmarkscreation, cross linking as per regulatory guidelines.• Skilled at working independently and collaboratively in ateam environment.• Co-ordination with Alliance Liaisons/Author for report QA error resolution.
Education
Mumbai University Mumbai
Bachelor of Pharmacy - BPharm, b pharm
2017 — 2021
Vighnaharta Trust s Shivajirao S Jondhale College of pharmacy Asangaon Tal Shahapur Dist Thane
Bachelor of Pharmacy - BPharm, Pharmacy
Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon
Master of Pharmacy, Pharmaceutics and Drug Design
Kavayitri Bahinabai Chaudhari North Maharashtra University (KBCNMU), Jalgaon
Master's degree, Pharmaceutics
University of Mumbai
Bachelor of Pharmacy - BPharm, Pharmacy
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.