Prateek Kumar Pathak
Medical safety lead at Novartis
- Role
- Medical Safety Lead at Novartis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Prateek Kumar Pathak
A pharma professional, with more than 10 years of total experience in scientific writing and pharmacovigilance. Involved in writing and QC of various safety reports for global regulatory submissions, including Periodic Benefit Risk Evaluation Reports (PBRERs), Signal detection reports, Risk Management Plans, Addendum Reports (AR), Annual Reports (IND and other), Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Bridging reports, health authority requests and other clinical documents, as assigned. Act as a mentor for new joinees
Experience
Medical Safety Lead
Sep 2025 — Present · Hyderabad, IN
Education
Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR)
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2004 — 2008
New Green Field School - India
High School
2001 — 2002
Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR)
Master of Pharmacy, Clinical Research
2008 — 2011
New Green Field School - India
High School
2003 — 2004
Skills
- Life Sciences
- Signal Detection
- Pbrer
- Regulatory Submissions
- Clinical Data Management
- Good Pharmacovigilance Practices
- Standard Operating Procedure (Sop)
- Meddra
- Psur
- Healthcare
- Microsoft Office
- Regulatory Affairs
- Lifesciences
- Medical Writing
- Arisg
- Ich-Gcp
- Psurs
- Gcp
- Clinical Trials
- Clinical Research
- Pharmaceutical Industry
- Sop
- Fda
- Drug Safety
- CRO
- Pharmaceuticals
- Regulatory Requirements
- Pharmacology
- Oncology
- Good Clinical Practice (Gcp)
- 21 Cfr Part 11
- Pharmacovigilance
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