Vinod Bhosale Email & Phone Number

Boston, Ma, Us

Cambridge, Massachusetts, Us

Waltham, Massachusetts, Us

Cambridge, Ma, Us

Safety and Regulatory Quality, Vendor / Business Partner Compliance Oversight, Audits and Inspection

Research Triangle Park, North Carolina, Us

- Creating productivity and quality decks for entire team- Lean Certified and Validation Processes (IQ, OQ, and PQ) - Creating Project documents, pre-project plan and executing transition plan- Good understanding of RFPs, RFQs and RFIs- Creating pre-project plan and executing transition plan- Creating project related artefacts and tracking mechanism- Management of Personnel resources (Hiring, recruiting, Effort estimations)- Manage day-to-day operations in a specific part of the process for drug safety data management or clinical data management (could be a combination of Case Entry, Medical Coding, Safety Narrative Writing, QC, Medical Review) - Ensure delivery of services meets or exceeds Service Level Agreements- Help Head of Services Delivery in hiring, training, managing and retaining delivery resources - Implement process & productivity improvements as appropriate to improve operational efficiency

Research Triangle Park, North Carolina, Us

• Work Force Manager: keeps track of the work progress and update the workflow with in-house tracking tool.• Point of Contact (POC) for all sorts of queries / meetings (conducted weekly and monthly).• Subject Matter Expert (SME). Audits and Inspection lead: was part of various FDA and MHRA audits. Extensive understanding of RCA and CAPAs.• Train, mentor, oversee and guide the activities of the Drug Safety Associates.• Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.• Maintain awareness and understanding of key governmental regulations and international standards relevant to device risk management (including post-market surveillance).• Worked extensively on MedDRA, WHO-drug dictionary and PubMed.• Help managing day-to-day operations in a specific part of the process for drug safety data management or clinical data management (could be a combination of Case Entry, Medical Coding, Safety Narrative Writing, QC, Medical Review)• Liaise with other functions (Quality Risk Management, Device Technologies, Project Management, etc.) to ensure timely completion of risk/benefit analyses in accordance with overall project timeline requirements • Identify process & productivity improvements as appropriate to improve operational efficiency.• Create, maintain and assume accountability for a culture of high customer service.• Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures• Maintained internal compliance and external reporting schedules for entire team.• Contribute to the implementation of new safety-related systems, processes and procedures (transition from ArisG to Argus safety database).• Submit and provide MedWatch, CIOMS or E2B reports as applicable to US FDA, EU and other countries via affiliates. Update the safety database with the submission date.

Mumbai, Maharashtra, In

- Pilot project of pharmacovigilance for biotech drugs/medicines, safety narrative writer/ medical reviewer and writing a draft company causality assessment statement. Working as Quality reviewer.- Perform triage on all case types and determine labelling and case assessment to determine prioritization, performing duplicate case searches and enter basic case data.- Generates concise, accurate and well-written case narratives.- Have worked on different case processing database environments like ARISg and ARGUS.- Processing raw adverse event cases which after quality review gets submitted.- As a Quality Reviewer (QC/QR) :- Have given constructive feedbacks as a case reviewer from the quality team (Handled a team of 4-5 case processors).• Assemble information, date stamp, image source documents, create paper and electronic folders, and associate electronic or paper information to electronic or paper as appropriate.• Identify duplicates and invalid case. Incorporate physician input, append case files and perform in process quality review for case receipt. • Worked on ICSRs, Single case expedited reporting, Clinical reports, SUSARS and periodic updates with understanding of US-FDA and international regulatory requirements.• Worked on different cases while focusing on major therapeutic areas like oncology, cardiovascular, bone health, nephrology, neuroscience, inflammation, and metabolic disorders.• Review safety data output for accuracy and completeness prior to submission to internal and external sources.• Writing case narratives for serious, non-serious and study reports, quality/product complaint reports.• Work closely with physician reviewers, clinical monitors and clinical sites and all members of the clinical project team including sponsors to ensure data accuracy and completeness.

Teaneck, New Jersey, Us

• Process Adverse Event Reports for both clinical and post marketed drugs within 24 hour limitation to meet with worldwide regulatory requirements for FDA and international subsidiaries, worldwide clinical research and medical scientific affairs and marketed drugs, biological products and devices.• Completion of risk and quality (label, approval, manual coding & quality review steps)• Clarification of unclear or illegible data from the call center.• Involved in processing of Product Quality Complaint Request forms and entering the Quality Assurance results.• Develop event rankings, create dechallenge/rechallenge determinations.• Writing comprehensive case narratives for serious, non-serious, literature reports, quality/product complaint reports.

Master'S Degree, Regulatory Affairs For Drugs, Biologics, And Medical Devices

Bachelor'S Degree, Pharmacy