Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Affiliations
Software
Interests
Cooking
Work Availability
Quote
Timeline
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BIJOY BAKAL

BIJOY BAKAL

Manager- Product Safety & Risk Management
Hyderabad,India

Summary

A post-graduate in Pharmacology (MD), with pharmacovigilance experience of approximately 5 years in CROs and core pharmaceutical organizations. Also have a clinical experience of more than 4 years in diverse hospital settings. Skilled in preparation and review of aggregate reports (PSUR/PBRERS, PADERs, ACO), Signal activities (Detection, Validation, Assessment), Literature review, Health authority request (RTQs), CCDS updates, COA and RMPS. Maintain an awareness of global regulatory reporting obligations and different safety profile of drugs. Collaborative team-player with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.

Overview

9
9
years of professional experience
9
9
years of post-secondary education
4
4
Certifications
1
1
Language

Work History

MANAGER- MEDICAL REVIEWER (PSRM)

Viatris
HYDERABAD
11.2021 - Current
  • Signal detection activities, PSURS, RTQs, ACO
  • CCDS updates/alignment, COA, Search criteria repository
  • Accomplished multiple tasks within established timeframes to achieve KPI by 99%.

TEAM MANAGER-MEDICAL REVIEW

Cognizant
Mumbai, IN
08.2020 - 10.2021
  • Performed signal detection, Signal assessment reports, Literature review, Post- authorization safety studies in metabolism and CVS domain
  • Training of new physicians
  • Aligned team goals and objectives with organizational strategy, aiding business growth.
  • Increased KPI above 98%

DRUG SAFETY PHYSICIAN

Parexel International India (Pvt) Ltd
CHANDIGARH
05.2018 - 07.2020
  • Performed review and drafting of PSUR/PBRERS, PADERS, ACO, Signal detection activities, Literature review, RMPs, Health authority request
  • Training of new physicians and medical writers on signal detection.
  • Decreased escalation to client by more than 50% on quality issues.

CONSULTANT MEDICAL OFFICER

Hindustan Latex Family Planning Promotion Trust
JORHAT
07.2017 - 04.2018
  • Conducted medical camps in far-reached areas
  • Managed team of more than 10 members which includes support staff, nurses, laboratory technicians and pharmacist
  • Exceeded goals through effective task prioritization and great work ethic

MEDICAL OFFICER

Sivasagar Civil Hospital
SIVASAGAR
05.2013 - 04.2014
  • Screened geriatic and high risk patients for Cancer, diabetes and hypertension
  • Attending to inpatient and outpatient focused on diabetic and oncology patients.

EMERGENCY MEDICAL OFFICER

Sampreeti Hospital and Research Centre
SIVASAGAR
12.2011 - 04.2013
  • Attended to emergency department and handling road traffic accidents, poisoning and other medical emergencies
  • Evaluated preliminary results and administered initial treatment such as stitching lacerations, splinting, casting broken bones or installing tubes and devices.

MEDICAL OFFICER

National Rural Health Mission
Sivasagar
11.2010 - 11.2011
  • Conducted medical camps, attending to Out patient department
  • Established consistent and accurate medical recordkeeping practices.

Education

M.D. - Pharmacology

Jorhat Medical College & Hospital
IN
05.2014 - 07.2017

Bachelor of Medicine & Bachelor of Surgery - Medicine

Assam Medical College & Hospital
IN
08.2004 - 07.2010

Skills

Therapeutic area expertise Metabolism & CVS

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Accomplishments

  • Gave oral paper presentation at national conference IPSCON 2016(PGI Chandigarh) & IPSCON-2017 (Ghaziabad)
  • Drafted aggregate reports for USA, EU region and rest of world

Certification

Professional diploma in Pharmacovigilance

Affiliations

1. Life Member of Indian Medical Associations

2. Life Member of North east Medical Pharmacological Society

Software

MS Excel

Interests

Pharmacovigilance

Drug discovery

Cooking

Love to cook as a stress buster and on weekends.

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote

When you want to give up, remember why you started.

Timeline

MANAGER- MEDICAL REVIEWER (PSRM)

Viatris
11.2021 - Current

TEAM MANAGER-MEDICAL REVIEW

Cognizant
08.2020 - 10.2021

DRUG SAFETY PHYSICIAN

Parexel International India (Pvt) Ltd
05.2018 - 07.2020

CONSULTANT MEDICAL OFFICER

Hindustan Latex Family Planning Promotion Trust
07.2017 - 04.2018

M.D. - Pharmacology

Jorhat Medical College & Hospital
05.2014 - 07.2017

MEDICAL OFFICER

Sivasagar Civil Hospital
05.2013 - 04.2014

EMERGENCY MEDICAL OFFICER

Sampreeti Hospital and Research Centre
12.2011 - 04.2013

MEDICAL OFFICER

National Rural Health Mission
11.2010 - 11.2011

Bachelor of Medicine & Bachelor of Surgery - Medicine

Assam Medical College & Hospital
08.2004 - 07.2010
BIJOY BAKALManager- Product Safety & Risk Management