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Pharmacovigilance Professional with 10 years of experience in leading pharmacovigilance and project management at Accenture. Proficient in Argus, Aris-G, and LSMV database management with knowledge of FDA, EMA, ICH, GVP, GCP guidelines. Expertise in process efficiencies, staff training, ICSR quality review, submissions, CAPA, Deviation Management, QMS, RCA and trend analysis.

Dynamic, customer-focused professional with over 10 years of experience in pharmacovigilance and pharmaceutical research and development. Proven expertise in global drug safety, aggregate safety reporting, regulatory submissions, and audits, complemented by strong proficiency in MS Excel. Skilled in managing teams, optimizing processes, drafting standard operating procedures (SOPs), and navigating diverse pharmacovigilance databases to ensure quality compliance throughout end-to-end PV processes. Committed to enhancing client engagement and driving excellence in safety management within the life sciences sector.

Jitesh Karthan is a university gold medalist in Bachelors of Pharmacy, a dual post graduate and a certified lean six sigma green belt holder having deep insights in service delivery and operational excellence. He is currently second line Manager with 7+ years of experience in Pharmacovigilance and 3+ years of experience in managing people, PV operations. He has exceptional social skills, communication abilities and is focused on smooth oversight of personnel and operational facets. He is a subject matter expert in Drug, Cosmetic, Medical Device and Nutraceutical Safety. He has worked in therapeutic areas of Immunology, Neurology, Women and reproductive health, dermatology. He has deep understanding on different safety databases and assists clients with business transitions, trainings and stabilizing teams. He has started his career with very ground level roles and his achievements over years includes successfully building new capabilities in affiliate case processing, local submissions, literature screening, Eudravigilance screening and global reconciliations between local safety officers and global case processing teams. He has also handled database migration, data cleansing projects in PV. He is a point of contact for quality assurance, risk and compliance teams. He constantly assists in process level checks, audit and inspection readiness. He has drafted standard working instructions for the new line of businesses. He has involved in building the world's first robot for patient safety for 2 pharmaceutical giants. He has done manual testing and assisted in computer system validation teams for natural language processing and AI enabled tools built at Accenture. He wants to work in higher roles for higher purposes to make a difference and add value in workstreams and patient health.

A multi-skilled professional seeking a challenging position within the Pharmaceutical industry where I can best utilize my acquired knowledge, and capitalize on challenging opportunities for advancement in the field of Pharmacovigilance.
An overall 12 years of Pharmacovigilance professional experience with strong technical skills to handle diverse global pharmacovigilance activities in Clinical Trials and Post Marketing phases of product lifecycle. Strong knowledge on Pharmacovigilance setup and can handle the global pharmacovigilance obligations of the diverse regulatory authorities with the aim of 100% quality and regulatory compliance and drive towards new levels of success and meeting business goals, in a highly competitive and fast-paced environment. Proficiency in Global Pharmacovigilance activities including ICSRs (end to end activities), PSMF (Preparation & maintenance), SDEAs (Preparation and maintenance), PADERs, PSURs/PBRERs/ACOs (preparation, review, eCTD compilation and submission), Signal Management, global RMPs (Expertise in drafting and review), Handling of queries from agencies (RFIs, PSUSA queries, RMP queries), Preparation of Standard Operating Procedures (SOPs). Actively participated in FDA inspection (GMP Audit; Product Quality Complaints; Spontaneous Reports from market; Pharmacovigilance) in Dec'16 at Hetero and five (5) days FDA inspection (Pharmacovigilance) in Jul'18 at Micro Labs Ltd.

Dr. Pakki Kausik

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Pharmacovigilance Services Analyst

Drug Safety Associate

Junior Drug Safety Associate

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Doctor of Pharmacy -

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Pharmacovigilance Services Analyst

Drug Safety Associate

Junior Drug Safety Associate

Doctor of Pharmacy -

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