Dr Rahul Somani

💠Responsible for Global Pharmacovigilance activities of Alkem subsidiaries, covering marketed products and clinical trials. 💠Successfully handled Pharmacovigilance Inspections by Regulatory Authorities like Kazakhstan & Ukraine. 💠Compliance – Customer-Centric – Cost-Effective

💠Responsible for Global Pharmacovigilance activities of Alkem subsidiaries, covering marketed products and clinical trials.

💠Responsible for Global Pharmacovigilance activities of Alkem subsidiaries, covering marketed products and clinical trials. 💠Successfully handled Pharmacovigilance Inspections by Regulatory Authorities like USFDA & TGA.

→Global Pharmacovigilance & Drug Safety Operations →Establishing & Scaling PV Departments →Compliance & Inspection/Audit Management →Risk Management & Regulatory Compliance →Quality Assurance & Workload Optimization →Vendor Evaluation, Negotiation & Finalization →Leadership, Talent Acquisition & Team Development →Training, Documentation & Process Optimization →Strategic Digital Tool Evaluation & Implementation →Public Speaking & Industry Thought Leadership

💠Lead- Established and maintained pharmacovigilance standards and processes to support Global Pharmacovigilance operations. 💠Lead- Medical Affairs (Acute Business): →Lead for acute portfolio, ensuring ethical and scientific product promotion. →Supported new product launches, medico-marketing strategies, and promotional material development. →Addressed medical queries from field teams and physicians; delivered CME content in collaboration with KOLs. →Conducted sales force training during briefing cycles to strengthen medical knowledge. →Led initiatives: 3T (Track-the-Topic), 3A (Alkem's-Academic-Advancement), and medical newsletters (PAN, OXUM, URSOKEM, ACE Insights). →Contributed to Business Development (product evaluations) and Regulatory Affairs (dossier support, pack inserts, FDC justifications). 💠Lead- Marketing Compliance: →Prepared guidelines on the basis of Uniform Code for Pharmaceuticals Marketing Practices (UCPMP). →Developed online system for approval of scientific contents in promotional materials & activities. →Conducted audits for ethical marketing practices for internal customers.

Sinhgad College of Pharmacy →Led the Department of Pharmacology, managing faculty, staff, and UG/PG students. →Coordinated state and district-level seminars, symposia, and CME programs for pharmacists and healthcare professionals. →Authored and co-authored 100+ scientific publications and presentations in reputed journals and conferences. →Actively presented research at national and international pharmacology conferences. →Guided UG, PG, and PhD students, mentoring them through successful research projects. →Conducted regular project evaluation meetings and assigned academic/research tasks based on strengths and interests. →Drafted research protocols and grant applications to agencies such as ICMR, AICTE, and DST. →Established a Drug Information Centre for patients, improving access to reliable medical knowledge.

Smt S S Patil College of Pharmacy →Taught and mentored UG students in pharmacology and clinical research. →Guided early-stage student research projects, laying foundation for later advanced studies. →Published and presented papers at national and international conferences. →Organized and participated in academic seminars and symposia. →Contributed to scientific writing and research protocol development.