Senior Aggregate Report Physician at Clinchoice (2022-05 – Present)
- Perform medical review for various Aggregate Safety Reports (Including but not limited to PBRER/PSUR, ACO, RMP, DSUR, PADER, EU-MDR PSUR, CAR, Ad-hoc safety reports, etc.) for medicinal products and medical devices for submissions to various health authorities as per the requirement.
- Participate in Safety Signal Management activities, including literature monitoring and validating the evidence from the signal perspective. Contribute to maintaining signal detection schedules, retrieval of safety data and reviews, and documentation of signal assessments/detections, signal validation, and evaluations, authoring and reviews of signal evaluations or ad-hoc safety reports on a need basis.
- Performs Medical Review of ICSR coding. Review seriousness, expectedness/ listedness, and perform causality assessment of each event in the ICSR.
- Provide medical assessment comment(s) for applicable ICSRs.
- Review due diligence queries as needed and raise additional medical queries for pertinent information regarding ICSR.
- Interact with sponsor stakeholders, present the key findings from the safety data evaluation, and assist in the decision-making regarding safety topics, signals, and risks.
- Provide key recommendations for the identification of important and non-important risks, frame search methodologies for safety database searches, and strategize safety section presentation in aggregate reports.
- Maintain PV expertise and understanding of international safety regulations and guidelines such as GVP Modules V, VI, VII, and IX, ICH E2C R2, ICH E2F, EU MDR, 21 CFR 314.80/ 600.80, and Health Canada GVP GUI-0102. Perform and impact assessment on client conventions based on changing regulatory guidelines
Assistant manager-pharmacovigilance-Medical Safety, Signal and Risk management at Fresenius Kabi (2022-02 – 2022-05)
- Perform medical review of ICSRs, including but not limited to verification of MedDRA coding, event pulling, causality assessment and expectedness assessment. Responsible for writing lucid and medically cohesive company causality comments in ICSRs.
- Perform medical review of literature articles as a part of signal detection activity and medical review of other signal management reports.
- Perform medical review of aggregate reports, including but not limited to benefit risk evaluation, literature evaluation and evaluation of risks and signals.
- Perform medical review of Risk Management plans.
- Ensure high quality of ICSRs, aggregate and signal management activities.
- Participate in safety label update activities for assigned products
- Provide product and therapeutic area training to the PV team.
- Provide cross-functional training on pharmacovigilance to the medical writing and the ICSR team members
- For Signal Management, perform manual interpretation of data generated from the safety database, review of drug-event pairs for further monitoring and signals identified from multiple sources of safety data, including literature and regulatory sources.
- Conduct validity check of individual case safety reports from clinical trials, spontaneous and literature reports
- Identify, support, and implement continuous improvement activities and, if required, coordinate with other VCCs/colleagues
- Ensure regulatory compliance under applicable global regulations.
- Draft responses for assigned queries received from regulatory agencies.
Pharmacovigilance - Sr. Drug Safety Physician at Bioclinica India Ltd (2020-06 – 2021-10)
- Medical review of ICSR (clinical trial)
- Client communication
- Quality data analysis and feedback process management
- Coordinate all post-marketing regulatory reporting and PV activities for assigned products to be carried out by the Bioclinica aggregate reporting team.
- Preparation of sections of medical significance/inputs for aggregate safety reports such as PSUR, PBRER, and Periodic Adverse Drug Experience Report (PADER).
- Responsible for the medical assessment, recommendation, and conclusion section of the Aggregate Safety Reports.
- Planning, organizing, and managing daily work to meet service-level timelines and deliverables.
Pharmacovigilance - Sr. Drug Safety Physician at Bioclinica India Ltd (2020-06 – 2018-03)
- Medical review of ICSR
- Client communication
- Quality data analysis and feedback process management
Pharmacovigilance - Medical Reviewer (Business Process Lead) at Tata Consultancy Services (2014-12 – 2016-03)
- Medical Review of ICSR (Fertility Products)
Sr. Medical Analyst at IKS Healthcare (Inventurus Knowledge Solutions) (2014-06 – 2014-12)
- Data analysis of the medical records.
- Managing day-to-day activity with process compliance, productivity, and quality.
- Process related data analysis and publish monthly records.
Duty Medical Officer at Parul Institute (2013-02 – 2014-06)
- Managing Ward patients.
- Follow up on their blood and diagnostic reports and take appropriate action accordingly.
- Updating the Consultant about the status of the patient and changing medications.
- Counselling relatives/attendants of the patient daily.
- Generating a census report for each month and submitting it to the Medical Superintendent
Critical care medical officer (MICU) at Rama Medical College and Research Hospital (2012-12 – 2013-11)
- Managing ICU patients.
- Intubation, Central Line insertion, Ventilator setup, Bi-pap setup.
- Follow up on their blood and diagnostic reports and take appropriate action accordingly.
- Updating the Consultant about the status of the patient and the changed medications.
- Counselling relatives/attendants of the patient daily.
- Managing the nursing staff schedule
- Generating a census report for each month and submitting it to the Medical Superintendent
- Presenting the Morbidity and Mortality census
Medical Officer at Shanti Gopal Hospital (2011-03 – 2012-12)
- Managing casualty patients
- Providing primary and secondary treatment
- Admission of patients and investigation orders
- Inform consultants about patients, orders and inform reports accordingly.
