Vrajeshkumar Patel Email & Phone Number

Over all 7+ years of experience, in drug safety / Medical Information / Post marketing activities / safety report writing / Cosmetics Quality and Regulatory. I have proven abilities in the field of Pharmacovigilance (PV) with vast backbone in team management, Pharmacovigilance, Quality reviewer, Safety medical writing (PADER /PSUR /PBRER /AR) and mentoring exposure. I have the edge in managing dynamics of regulatory requirements and timelines. Always created and maintain win-win environment through collaborating with my peers & seniors. Also, always been willing to take new challenges, learn new things and been flexible to contribute. Creativity driven, quick learning, team spirit and quality end results.Masters in Pharmacy (Pharmacology) and Associate’s Biotechnology PG Diploma.Regulatory and Clinical guidelines: USFDA, ICH, Health Canada, EMEA (GVP), GCP, TGA, GMP.Safety databases: ARGUS (3 years), AERS (2 years), PvNet (2 years), KnowledgeNet (1 year), eCTD submissions of PADERPast Experience:PV case processing - ICSR, PMS, Clinical, Literature. Medical and adverse events coding, narrative writing, labeling, accessing causality, Quality reviewer (ICSR / Aggregate reports), Safety Medical writer (PADER /PSUR /PBRER / AR), Acting as back up leader for ICSR team and quality review team. Updating SOP’s, WI’s and guidance documents by collaborating with QA team. Contributing in management of project to meet the quantity and quality requirements and mentoring new joiners.Technical Skills:Advanced MS Office, Adobe Acrobat, eCTD submission activities (bookmarking, hyperlinking, table of contents etc.), MedDRA, WHO DD coding.

Listed skills include Pharmacovigilance, Ich Gcp, Medical Writing, Regulatory Affairs, and 9 others.