Nazim Shaikh

Junior PV Officer with over 11 years of experience in the pharmacovigilance. Expertise in MedDRA coding, RAVE database processing, and quality review of clinical cases drives efficient case intake and validation processes. Proficient in enhancing operational workflows through effective communication and problem-solving skills.

Committed to mentoring new talent while ensuring adherence to stringent quality standards in case processing and reporting. Ready to tackle new challenges and contribute to projects in a dynamic environment.

Junior PV Officer (PrimeVigilance) at Ergomed Clinical Research Private Limited (2025-09 – 2026-04)

Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines

• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
• Performing ICSR follow up, AE/SUSAR Management, MedDRA and WHO coding

Subject Matter Expert at Cognizant Technology Solutions (2021-06 – 2025-09)

MedDRA subject matter expert and quality reviewer specializing in ICSR processing, case intake validation, and SUSAR case management

• Assignment of clinical case intake activity, collating and validating case intake data on daily basis and sharing data with clients
• Working as MedDRA subject matter expert (SME) - Coding of various AE, medical history, indication, labs and other procedure using most appropriate lower-level term (LLT) from MedDRA
• Working on RAVE database for processing and quality review of clinical serious and SUSAR cases
• Working as quality reviewer of SUSAR cases, processing serious clinical cases along with SUSAR cases
• Complete distribution record for serious case
• Worked on blind break activity of protocols
• Assist in training and mentoring of new joiners

Senior Process Associate at Tata Consultancy Services (2019-01 – 2021-06)

Case intake assessment, data entry, database search, MedDRA coding, and distribution record management for serious cases

• Intake activity with assessment of valid and non-valid cases, receive information on AE, initial check and data entry, and search database to prevent duplicate, AE evaluation for possible upgradation
• Coding of suspect drug from CPD in Argus
• Coding of various AE, medical history, indication, labs and other procedure using most appropriate lower-level term (LLT) from MedDRA
• Complete distribution record for serious case

Junior Data Analyst at Cognizant Technology Solutions (2014-12 – 2019-01)

MedDRA coding, database management, case narrative generation, and quality query management in pharmacovigilance

• Working as MedDRA subject matter expert (SME), receive information on AE, initial check and data entry, and search database to prevent duplicate, AE evaluation for possible upgradation
• Coding of suspect drug from CPD and other product from WHODD in AEGIS database
• Coding of various AE, medical history, indication, labs and other procedure using most appropriate lower-level term (LLT) from MedDRA
• Complete distribution record for serious case
• Generate Case Narratives (ANG) & Queries on Drug Interaction and adverse effects
• Management of the Queries according to the volume flow
• Interaction with managers regarding problem solving and understanding the process
• Regular Update session regarding new medical terminologies. Basic knowledge on CAPA, RCA and Quality assessments
• Assist in training and mentoring of new joiners

Bachelors in Pharmacy – Pune University (2014-01)

Diploma in Pharmacy – MSBTE (2011-01)

HSC – Maharashtra State Board (2009-01)

SSC – Maharashtra State Board (2007-01)