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Dedicated and detail-oriented Pharmacovigilance Specialist with 8 years of experience in drug safety. Expert in regulatory compliance and risk management. Strong analytical and database management skills. Effective at enhancing team quality and training new hires.

Detailed oriented Pharmacovigilance professional with 2 years and 8 months of experience as a Senior Drug Safety Associate, adept at ensuring compliance with regulatory requirements and contributing to the safe use of pharmaceutical products. Seeking to leverage expertise in Clinical Data Management to excel in a challenging role within the pharmaceutical industry, while continuously advancing knowledge and skills.

To work in an organization where can acquire new knowledge, sharpen my skills, and put effort into achieving organizational as well as individual goals. Experienced in drug safety with focus on case processing. Strengths lie in understanding of pharmaco-vigilance protocols along with strong attention to detail and ability to manage multiple tasks. Improved in efficiency of reporting processes and maintaining high levels of data accuracy.

Drug Safety Professional and Registered Pharmacist with 10 years of experience in all aspects of project management, ICSR case processing, assessing safety data, reporting and submissions, authoring aggregate reports for assigned products, performing signal management process and document management in Veeva. Expertise in MedDRA coding, expedited reporting and remarkable knowledge of US and ICH safety reporting regulations and guidelines. Providing root cause analysis (RCA) and implemented CAPA for authority. Local pharmacovigilance monitoring and perform impact assessments for regulatory documents. Experience in leading cross-functional teams and taking initiative to understand assignments. Core team member in PV automation (ArisG to LSMV, E2B R3 implementation) to meet regulatory requirements and strengthen drug safety. Signal Management (end-to-end) and performing Benefit-Risk Analysis and UAT testing. Experience in health authority inspections/internal audits and served as PV regulatory SME.

Nirbhay Kumar Prabhakar

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Patient Safety Associate

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Master of Pharmacy - Pharmacology

B. Pharm - Pharmacy

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Patient Safety Associate

Master of Pharmacy - Pharmacology

B. Pharm - Pharmacy

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