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A deligent and highly motivated Pharmacovigilance Physician with over a decade experience in pre and post marketing surveillance . With vast experience in drug safety operations, clinical development and data management. An excellent blend of clinical expertise, PV leadership experience and detailed understanding of the pharmaceutical industry. Seeking to leverage expertise for enhancement of patient safety in drug development and post marketing surveillance.

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.

More than 2 years of experience in PV and Gaining Knowledge in Pharmacovigilance (PV) activities including Medical review of Individual Case Safety Reports (ICSRs). Aiding for cases from a medical perspective to PV Scientists who participate in processing ICSRs, assessing events for coding, MedDRA (Medical Dictionary for Regulatory Activities) coding of adverse events

Physician functioning in pharma industry for 7 years with Pharmacovigilance experience. Reviewing and approving appropriate selection of adverse events (AE) from source documents, assigning appropriate coding for AES, medical history and concomitant medications with MedDRA and WHO-Drug dictionaries. Verifying the determined seriousness of the case Performing or review of ICSR case assessment including listedness/ expectedness, of the Adverse events with Reference Safety Information (IB, CCDS, SmPC, USPI) Oversight of medical review cases done by vendor and providing inputs on assessment and medical evaluation comment Providing medical safety input, and reviewing or drafting sections of response documents to health authority inquiries, as appropriate. Identifying, reviewing and un-blinding (If applicable) SUSAR cases Reviewed aggregate safety data to provide medical input into aggregate safety reports such as PBRER, DSUR, PSUR, PADER. Experience in Signal management activities with expertise in authoring signal evaluation reports and recommending next steps of action to senior management. Experience in review of clinical trial protocol, CRFs, Investigator’s brochures, Informed consent forms and CSR Maintaining an excellent knowledge profile of assigned drugs, Reviewing and updating RSI documents on safety database Liaise with Medical Monitor for co-ordination and reconciliation of Immediately Reportable Events (IREs) between site and Safety Team. Supported global clinical development, medical affairs, data sciences and regulatory activities as the pharmacovigilance representative. Proficient in Safety databases such as ARGUS, ARISg, Rave, Rave-X, Jarvis, Veeva Vault, CDOD, Empirica, etc High level of understanding of applicable regulations, including FDA (21CFR 312 and 314), ICH (E2A, E2B, E2C), GCP guidelines, EMA regulations, GVP Modules, etc. Mentoring and training new staff as required for overall understanding and compliance of the company.
Dedicated healthcare professional with strong foundation in pharmacovigilance and patient safety. Proven ability to assess and mitigate drug-related risks, ensuring compliance with regulatory standards. Known for fostering team collaboration and delivering reliable outcomes in dynamic settings.

RAHAT SHARMA

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Drug Safety Physician

Duty Medical Officer

Medical Officer

Intern

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Drug Safety Physician

Duty Medical Officer

Medical Officer

Intern

MBBS - undefined

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