AMIT AMBESANGE
Mumbai
Summary
Drug safety physician with foundational skills in medical review in drug safety and pharmacovigilance and demonstrated expertise in medical evaluation of adverse events of pharmaceutical products. Seeking a Drug Safety role to leverage expertise in ICSRs, PADERs, and PBRERs to ensure patient safety and regulatory adherence.
Overview
11
11
years of professional experience
Work History
Manager Drug safety
Cipla
08.2024 - Current
- Medical review of Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), safety summary reports. Review of search criteria for PBRERs
- Evaluate regulatory intelligence activity based on safety concerns identified from the Regulatory authorities. Participate in DSRC meetings.
- Medical review of ICSRs (individual case safety report) in argus database. Perform triage. Resolve vendor queries. Provide training to the safety specialists and associates.
Deputy Manager Medical
Alkem Laboratories ltd.
07.2022 - 08.2024
- Medical review of ICSRs in Argus database. Perform medical review including verifying the coding & labeling, reviewing seriousness, narratives, causality statement, medical aspect of follow-up request.
- Vendor management and oversight of ICSR activities. Monitored vendor performance against service level agreements and to ensure continuous quality assurance. Addressed vendor concerns pertaining to ICSR and literature activities to assist with case related issues.
- Literature surveillance: Screening & Scientific Review and Assessment. Perform triage assessment
Senior Critical Care Registrar
Jaslok Hospital & Research Centre
10.2020 - 07.2022
- Provide continuous vigilance of care and demonstrated clinical competency in critical care interventions. Performed regular rounds, document assessment on ICU patients. Evaluate each patient after admission and notify consultants of assessments and formulate a treatment/management plan.
- Perform critical care procedures like Central line, Dialysis line and arterial line placement, endotracheal intubation, lumbar puncture.
Resident Medical Officer-Critical Care& Anesthesia
Bombay Hospital & Medical Research Centre
11.2019 - 09.2020
- Practiced a broad range of skills including intubation, regional techniques, spinal and epidurals, multiple CSEs and administered anesthesia to multiple patients requiring surgical procedures.
- Led team discussions regarding best practices for airway management in difficult cases. Provided direct patient care and management of critically ill patients in a Covid ICU setting and developed plans of care and intervened as per critical care guidelines.
Anesthesiology Resident
Rajiv Gandhi Medical College And Chatrapati Shivaji Maharaj Hospital
06.2017 - 05.2019
- Provided and administered anesthesia to multiple patients requiring laparoscopic, obstetric orthopedic, general surgery, ENT, gynecological procedures. Evaluated patients' pre anesthetic check up(PAC). Provided post-anesthesia care including pain management and counteracted emergent complications and adverse events.
- Demonstrated competency and acquired a broad range of skills in the field including intubation, regional techniques, spinal and epidurals, USG guided central line insertion.
Emergency Medical Officer (House Officer)
Global Hospital
02.2017 - 05.2017
- Provided emergency medical care to patients in a high-pressure environment. Triaged incoming patients. Performed emergency resuscitations. Independently performed minor surgical procedures such as suturing, urinary catheterization, wound dressings, slabs and casts for fractures, venous cannulation etc.
- Analyzed patient presentations, reports and findings to determine a working diagnosis and thus formulated treatment plans after discussion. Ordered and executed diagnostic investigations including imaging.
Resident Medical Officer - ICU and Medicine Dept
Bombay Hospital & Medical Research Center
03.2016 - 01.2017
- Documenting patient presentations to make accurate determinations of a provisional or working diagnosis, and thus formulate a treatment plan after discussion with consultants.
- Conducted daily rounds on hospitalized patients and provided care in accordance with established internal medicine guidelines. Wrote admissions notes, care plans,progress notes, patient prescriptions.
House Officer (General Medicine)
Kurla Bhabha Hospital
11.2014 - 01.2015
- Documenting and evaluating patient histories, complaints, and symptoms. Managed inpatient services including admission orders, care plans, drug sheets,progress notes and daily rounds.
Education
MBBS -
Dr Ulhas Patil Medical College & Hospital
09.2014
Skills
- Medical Review of ICSRs, PADERs, PBRERs, SSRs
- Vendor oversight and pharmacovigilance training
- Knowledge of FDA regulations and EMA guidelines
- Argus and MedDRA
RESEARCH EXPERIENCE
Indian council of medical research- Short term studentship__ Use of non-pharmacological ways of hypertension management in rural population of interior of Maharashtra (04/2010 - 09/2010) Successfully carried out a cross-sectional study to evaluate the incidence of compliance of diagnosed hypertensive patients towards non- pharmacological/ lifestyle modifications, sample size being 265 patients. Yet to be published.
Part Time Research Experience
Indian council of medical research- Short term studentship
Successfully carried out a cross-sectional study- Use of non-pharmacological ways of hypertension management in rural population of interior of Maharashtra (04/2010 - 09/2010) to evaluate the incidence of compliance of diagnosed hypertensive patients towards non- pharmacological/ lifestyle modifications, sample size being 265 patients.
Timeline
Manager Drug safety
Cipla
08.2024 - Current
Deputy Manager Medical
Alkem Laboratories ltd.
07.2022 - 08.2024
Senior Critical Care Registrar
Jaslok Hospital & Research Centre
10.2020 - 07.2022
Resident Medical Officer-Critical Care& Anesthesia
Bombay Hospital & Medical Research Centre
11.2019 - 09.2020
Anesthesiology Resident
Rajiv Gandhi Medical College And Chatrapati Shivaji Maharaj Hospital
06.2017 - 05.2019
Emergency Medical Officer (House Officer)
Global Hospital
02.2017 - 05.2017
Resident Medical Officer - ICU and Medicine Dept
Bombay Hospital & Medical Research Center
03.2016 - 01.2017
House Officer (General Medicine)
Kurla Bhabha Hospital
11.2014 - 01.2015
MBBS -
Dr Ulhas Patil Medical College & Hospital
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