Rahul Rahul Email & Phone Number

India

India

Responsible and accountable for the customer-focused leadership in managing and delivering the operational and financial aspects of clinical projects from start up to final deliverables and ranging in size and complexity from single service studies to full scope, multiple protocol projects and/or global projects across various phases. Acts as a primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement. Directs the technical and operational aspects of the Safety & Pharmacovigilance (SPVG) deliverables of the assigned projects. Accountable for the delivery of all contracted safety activities on time, on budget, and in compliance with all applicable regulations. Develops integrated SPVG project/program delivery timelines and reports weekly progress including plans to address potential risks/gaps to the project team, Higher Management and Project/Program Sponsor/Customer. Participates in audits and inspections. Provides guidance and expertise for all tasks associated with ICSR processing and submissions, Periodic/Annual Submissions, Regulatory Intelligence, and training. Participates in the development and review of departmental policies and procedures as controlled documents adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs.

Mumbai Area, India

Role as a Subject Matter Expert (Trainer):- To conduct and facilitate refresher trainings for all the associates as and whenrequired. - Identify changes and update training plans regularly. - To help in mentorship of associates. - To help Cognizant Query mailbox in regards to complex case processing questions.Role as a Case processor- Quality Reviewer:Responsible for completion of day-to-day work and process flows within the agreed servicelevels (SLAs). Co-ordination with team on problem solving initiatives. Receive information on adverse events, perform initial checks, search database to preventduplicate entries. Medical judgment is exercised in deciding whether an upgrade is appropriate and the upgradeis documented. Ensure scientific rigor through accurate, complete and consistent data entry of adverse eventreports from source documents with emphasis on timeliness and quality. An upfront clarification requested in case of data discrepancy. Evaluate case information for Medical completeness and finish processing of all AE reports,including review for completeness and accuracy. Coding of Company suspect drugs with company product dictionary (CPD) & review coding ofother company suspect drugs, concomitant, past and treatment drugs using WHO DD in thedatabase. Create and update case narrative. Work as a Quality reviewer to improve the quality. Assist with related administrative and procedural activities as required or requested.

Masters Degree In Pharmacy, Pharmaceutics And Drug Design

Bachelor'S Degree, Pharmacy

Education record