Sachin Nandedkar

-Responsible for scientific and medical writing and/or critically editing the deliverables for Safety and Medical Affairs department. -Ensures the reports files are linked to appropriate Quality Systems and Regulatory documents -Act as SME during audits and inspections -Actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.

-Initiate and manage the Pharmacovigilance activity of the Company encompassing all the plants -Liaison with European and African development agencies, for technical support and to create visibility for the company -Manage Medical Affairs activities of the company -Support the Regulatory Affairs department in preparing dossiers, managing queries from the Regulatory Authority, and coordinating with cross-functional teams to register products.

-Lead the projects related to Clinical Evaluation Reports, PSUR and RMP for Medical Devices

-Creating and updating SOPs, Working Practices, -Quality Excellence and Inspection Readiness -Subject Matter Expert for Legal Reports and Technical Complaint Reports (Annual Product Quality Reports) -Handling and Managing CAPAs, Quality Sustenance Plans and Audit Support.

-Quality Review of Individual Case Safety reports -Project lead for quality plans and projects -Process change and Subject Matter Expert -Developing, monitoring process related metrics and timely release of monitoring reports

-Safety monitoring by optimizing scientific quality documentation and data entry of Safety case reports for Company drugs -Responsible for administrative and procedural activities, training and mentoring other Safety Processing associates -Implement quality improvement plans and process validation activities -Contributor for writing activities like aggregate reports, standard operating procedures, process related documents and product guidance documents

-Responsible for the receipt, tracking, acknowledging and initialization of single case drug safety reports into the Patient Safety database -Perform accurate data entry and coding of adverse event reports and evaluation of reports within defined time frame, in compliance with company business rules, standard operating procedures and regulatory requirements -Work with Country Safety Departments, License Partners, Medical Function to ensure that reports are accurately collected, evaluated and data based

-Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file, acknowledge and initialize received drug safety reports in the tracking tool and/or Safety database. -Use medical dictionaries and business guidance to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case report -Assist with related administrative and procedural activities as required or requested

Pursuing

Pursuing

-Clinical Research -Pharmacovigilance -Regulatory Affairs -Pre-Clinical Studies -Good Clinical Practices, Good Manufacturing Practices

-Pharmacology and Toxicology -Pharmaceutical Chemistry -Medicinal Chemistry -Pharmaceutical Analysis -Pharmaceutical Sciences

Mathematics, Physics, Chemistry

General Schooling