Vipin Jain
Senior Drug Safety Specialist at FIDELITY HEALTH SERVICES
- Role
- Senior Drug Safety Specialist at Lupin
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Vipin Jain
I am highly self-motivated and goal-oriented professional committed to pursuing a…
Experience
Senior Drug Safety Specialist
May 2017 — Present · Mumbai, IN
Working for quality improvement plan and Part of a quality team for quality review and Assessment of the processed and reported adverse event.• Quality review of individual case safety reports which can be of literature, clinical trials, E2B, regulatory authority and spontaneous sources.• Management of complete incoming safety information.• Evaluate case information for Medical completeness.• Quality reviewing and mentor checking ICSRs processed by newly joined associates.• Responsible for taking sessions for maintain and improvement of quality for all team by discussions. • Provide ideas to improve quality of project as well as improve speed of system developed. • Monitoring compliance of late cases and deliverables and doing root cause analysis about cases missing internal KPI timelines as well as regulatory timelines.• Submissions of expedited reports to the FDA, Health Canada, TGA and other health authorities.• Experienced in providing training and signing off the new joiners for data entry role and quality reviewer role.• Team lead of case processing team (new joiners for data entry role and quality reviewer role)/ back-up team leader.• Act as subject matter expert for ICSR processing, and quality review.• Preparing new SOPs and updating existing SOPs whenever required.• Liaison with client and relevant stakeholders for process enhancement, issue discussion and for any other requirement.• Involve in various activities such as audit, client call, appraisal, and recruitment etc.• Identify valid/potential ICSRs for processing and identifying articles with significant safety assessments.• Monitoring team performance and quality improvement plans• Co-ordinating and conducting team meetings and support in growth of team members in the organization• Able to perform other duties as assigned by management including necessary administrative duties as required.• Determine expectedness/listedness against appropriate label.
Education
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Master's degree, Pharmacy
2008 — 2010
Skills
- Medical Writing
- Regulatory Submissions
- Regulatory Affairs
- Lifesciences
- Ich-Gcp
- Clinical Trials
- Protocol
- Pharmacovigilance
- Pharmacokinetics
- Edc
- CRO
- Gcp
- Ctms
- Pharmaceutical Industry
- Fda
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