Summary
Overview
Work History
Education
Skills
Timeline
Generic

Aniruddha Bhattacharyya

Hyderabad,TG

Summary

Seasoned Medical Doctor with over 20 years of comprehensive expertise, including more than 14 years of specialized experience within the pharmaceutical industry. Proficient in Pharmacovigilance and Medical operations across diverse therapeutic areas, with a focus on clinical trials and post-marketing experience. Demonstrated proficiency as a Subject Matter Expert in aggregate report preparation for both pre-marketing (DSUR) and post-marketing (PSUR/PBRER, PADER) phases of drug development. Skilled in managing product risks throughout the drug development lifecycle, including the development and review of signal detection documents, Signal detection and management plans, validation reports, and Signal evaluation reports. Actively contributed as a key member of the Global Functional Leadership team, particularly as a Regional Medical Lead Physician (APAC), overseeing teams of various sizes. Known for tackling challenges head-on, ensuring projects are completed with precision, timeliness, and adherence to quality standards. Proficient in navigating operational complexities and adept at resolving conflicts, consistently striving to enhance team effectiveness and drive success.

Overview

22
22
years of professional experience

Work History

Medical Director

PAREXEL International
11.2018 - Current
  • Subject matter expert for Aggregate reports, both pre- and post-marketing drug development phases including DSUR, PSUR/PBRER, PADER, NDA Annual report, Medical Impact assessment report etc.
  • Thorough knowledge and expertise in management of the safety profile of the drug throughout the developmental phases including Signal detection and management processes
  • Expertise in Risk management plans, especially in terms of providing medical inputs throughout for identification of safety specification, modalities for managing the risks including discussion and deliberations with cross-functional teams for identifying appropriate risk minimization strategies
  • Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products.
  • Perform medical monitoring for assigned studies – answering day to day medical and scientific questions; provide daily medical support to PAREXEL staff or site (Investigator/study coordinator).
  • Training on protocol and efficacy tools to site staffs, study team.
  • Provide medical advice and support for the feasibility.
  • Eligibility review – review of screening data (also randomization data where applicable) to confirm the subject is eligibility for the study.
  • End point review of clinical trial data – review of clinical trial data for their medical plausibility and to check if it was collected and entered as per study requirement and in accordance to protocol.
  • Managing and supervising regional Drug Safety physicians on a day-to-day basis, managing their performance in ongoing projects including quality of deliverables and compliance with the budget, providing technical and process-related expertise to drug safety management (clinical trial and post- marketing) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
  • Participate in Proposal Development Teams (PDTs) for client bid meetings
  • Maintain up-to-date knowledge of therapeutic area expertise by attending Global therapeutic meetings.

Associate Medical Director

PAREXEL International
11.2017 - 11.2018
  • Managing and supervising regional Drug Safety physicians on a day-to-day basis, guiding performance of Drug Safety physicians in ongoing projects in terms of quality of deliverables and compliance with the budget, as well as providing technical and process-related expertise to drug safety management (clinical trial and post- marketing) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
  • Participate in Proposal Development Teams (PDTs) for client bid meetings
  • Training on protocol and efficacy tools to site staffs, CRAs and data management team.
  • End point review of clinical trial data – review of clinical trial data for their medical plausibility and to check if it was collected and entered as per study requirement and in accordance to protocol.
  • Eligibility review – review of screening data (also randomization data where applicable) to confirm the subject is eligibility for the study.
  • Provide medical monitoring for assigned products – answering day to day medical and scientific questions; provide daily medical support to PAREXEL staff or site (Investigator/study coordinator).
  • Review all documents assigned for scientifically/medically relevant issues including drug safety.
  • Maintain up-to-date knowledge of therapeutic area expertise by attending Global therapeutic meetings.
  • Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products.
  • Provide medical input in all required safety reports, such as –but not limited to – PSURs, Clinical Expert Report, function as Pharmacovigilance representative/safety leader/senior technical lead on the projects, in Proposal
  • Provide medical advice and support for the feasibility

Senior Manager, Drug Safety Physician

Parexel International
11.2015 - 11.2017
  • Medical monitoring – answering day to day medical and scientific questions, provide daily medical support to PAREXEL staff or site (investigator/study coordinator)
  • Led cross-functional teams to achieve project milestones and deliver high-quality results.
  • Review and sign off adverse events report for accuracy and clinical importance for European Regulatory Authorities, FDA or other regulatory agencies;
  • Provide sponsors with periodic experience reports summarizing adverse events as required by the sponsor or authorities
  • Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
  • Review and sign off Data Management listings of safety data, establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities
  • Review and sign off technical documents written by PAREXEL with respect to medically relevant matters with particular attention to those relating to drug safety
  • Review coding of adverse events and concomitant medications for accuracy and consistency
  • Provide support for the preparation of clinical Review of o Literature Reports including epidemiological background research, Clinical trial reports, Study protocols, Clinical Trial (Serious) Adverse Event Reports, Post-marketing ADR reports,
  • Provide medical guidance to Safety Staff during the case processing cycle
  • Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
  • Assign Drug Safety physicians to projects upon request of Medical Business Operations and delegate work to Drug Safety physicians according to allocated budget/hours
  • Cooperate with Medical Business Operations and/or regional Head of Medical Sciences as appropriate to assign resources to new projects, and to assess staffing needs for current and future projects
  • Ensure that the work provided by the Drug Safety physicians is in accordance with the hourly budget provided by Medical Business Operations
  • Assist Regional Head of Medical Sciences/Head of PV Ops in interviews for recruitment of new personnel and in termination of employment as necessary
  • Organize, in conjunction with local QPT staff, mentoring and training (general and on-the job) for new staff and ensure continuous training within the department and with other departments, where appropriate
  • Perform annual appraisals of team, and provide recommendations

Associate Director

Dr Reddy’s Laboratories Limited
04.2014 - 10.2015
  • Supporting the investigator to handle safety related issues occurring on any study subjects
  • Performs pharmacovigilance activities for all assigned DRL projects or products including identifying and analyzing safety signals based on a comprehensive evaluation of post-marketing data and Serious
  • Adverse Events (SAEs) from clinical trials
  • Monitors the clinical safety of projects/products and responds appropriately
  • Performs medical assessment and related activities for single cases, including collecting additional follow- up information as necessary, medical evaluation of quality defects, review of line listings of single cases, and preparation of investigator notifications
  • Identifies safety signals based on the review of solicited or unsolicited single cases and confirm that they are not overlooked
  • Performs signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools
  • Vendor management, as the activity performed by the CRO needs regular oversight for compliance, and quality
  • The assessment of the data provided by the service provider and ensuring the project is being performed as per the applicable SOWs as well as SOPs
  • Sole channel of communication between the CRO and DRL for all escalations from DRL side
  • Works in collaboration to understand the constraints in the CRO environment and proper resolution of them.

Manager, Drug Safety Physician/Senior Drug Safety Physician

PAREXEL International
08.2011 - 04.2014
  • Provided comprehensive medical and scientific support to PAREXEL staff and site personnel
  • Reviewed and approved adverse event reports, ensuring accuracy and regulatory compliance
  • Conducted therapeutic area training sessions at internal and external meetings
  • Analyzed safety data listings to identify clinically meaningful trends and follow-up actions
  • Reviewed technical documents for medically relevant matters, emphasizing drug safety
  • Maintained consistency in adverse event and medication coding
  • Contributed to the development of clinical protocols, summary reports, and journal articles
  • Demonstrated round-the-clock availability to meet Pharmacovigilance timelines
  • Offered expert medical guidance throughout the case processing cycle
  • Managed assignments and workload delegation for Drug Safety physicians, optimizing resource utilization

Assistant. Manager

Lambda Therapeutic Research Limited
02.2010 - 07.2011
  • Provided leadership within the Senior Leadership team, addressing client queries on Medical Review and Signal detection activities
  • Contributed insights to Requests for Proposals (RFPs) and client inquiries for business development purposes
  • Ensured timely execution of Medical Reviews for individual cases (ICSRs) and PSURs as per SOPs
  • Orchestrated yearly schedules for Signal detection activities and ensured adherence to defined timelines
  • Managed daily operations to meet service level agreements and deliverables
  • Reviewed case metrics and documents for accuracy, providing guidance to team members as needed - Operational excellance
  • Conducted training on regulatory reporting regulations and guidelines for team members
  • Evaluated team performance and facilitated continuous improvement initiatives
  • Acted as a point of contact for client audits on Pharmacovigilance systems
  • Optimized resource allocation for efficient handling of backlog and routine ICSRs and PSURs
  • Provided medical expertise on complex adverse event cases and oversaw quality control of reportable cases

Team Leader

Accenture Services Pvt. Ltd
01.2009 - 01.2010
  • Review standard line-listings
  • Conduct analysis of single cases extracted
  • Retrieves PSUR populated model document and template from PRISM/CARA docbase.
  • Reviews duplicate, blinded and validated reports
  • Determines which cases are included in PSUR.
  • Writes and incorporates sections submitted by contributing authors and comments from physicians simultaneously.
  • Reviews all comments and updates for PSUR as appropriate.
  • Edits final draft and runs QC tools (internal documents only).
  • Submits final version of the report to the client.
  • Ensure consistency with quality, accuracy, and medical safety standards.
  • Ability to read quantities of highly structured data and transcribe data to fields according to business rules with high degree of quality.
  • Plan and organize work so that SLAs are realized.
  • Ensure quality standards are met as lay out by the client and Accenture.
  • Ensure compliance with business policy and contractual requirements.
  • Demonstrates the ability to work as a part of the team.
  • Seeking advice and escalating issues when facing tasks or problems outside the normal scope of the job.
  • Requires minimal supervision to manage daily activities and is able to meet published deadlines for activities.
  • Adaptable to learn new processes, concepts and skills

Medical Associate

Medicare TPA (I) Pvt. Ltd
12.2007 - 08.2008
  • Audit claim files, examine claim papers & medical reports according to disease, match prescriptions and in case of deficiencies of documents, put queries
  • Cross- check to drugs and medicines prescribed by physicians, review and processing etc
  • Responsible for Error free processing of pre-authorization request within the deadline
  • Ability to present status reports & escalate issues in a timely manner

In-Charge, Critical Care Unit

Sonoscan Hospital Pvt. Ltd
02.2006 - 07.2006
  • Expertise in the CCU jobs like Cardiac life support and ACLS
  • Have experience in dealing with day-to-day running of the CCU.
  • Insertion of Endotracheal tube
  • Handling of Mechanical Ventilators
  • Intercostal drain insertion
  • Temporary Pacemaker insertion
  • Central Venous access and monitoring of CVP & PCWP
  • Expertise in Hemodialysis done in patients on ARF or Acute on CRF

Attending Doctor, Critical Care Unit

Peerless Hospital & B.K. Roy Research Centre
05.2005 - 06.2006
  • Evaluated patient histories, complaints, and current symptoms.
  • Diagnosed and treated patients suffering from chronic conditions.
  • Provided emergent medical care and treatment for life-threatening injuries and illnesses.
  • Monitored post-operative recovery and educated patients on at-home recovery.

Resident Medical Officer, Dept. of TB and Chest

M.R. Bangur Hospital
01.2002 - 10.2003
  • As a Resident in this tertiary care Govt. hospital, trained in management of patients with Pulmonary/Extra pulmonary tuberculosis.
  • Trained in RNTCP program by MOH, Govt. of India
  • Management of tuberculosis patients including its complications and regular follow-up

Education

MBBS - Internal Medicine

Calcutta University
Kolkata, India
12.2001

PGDHA - Hospital administration

Apollo Hospital Education And Research Foundation
Hyderabad, India
12.2007

certificate course in “Pharmacovigilance & Pharmacoepidemiology - Pharmacovigilance

SYMOGEN INDIA
New Delhi, India
12.2008

Skills

  • PBRER/PSUR/PADER/ACO/NDA Annual Report/Medical Impact assessment Report
  • Signal detection and management
  • Risk Management
  • Strategic Planning
  • Staff Development
  • Patient Safety
  • Critical Thinking
  • Process Implementation and Improvement
  • Stakeholder Coordination

Timeline

Medical Director

PAREXEL International
11.2018 - Current

Associate Medical Director

PAREXEL International
11.2017 - 11.2018

Senior Manager, Drug Safety Physician

Parexel International
11.2015 - 11.2017

Associate Director

Dr Reddy’s Laboratories Limited
04.2014 - 10.2015

Manager, Drug Safety Physician/Senior Drug Safety Physician

PAREXEL International
08.2011 - 04.2014

Assistant. Manager

Lambda Therapeutic Research Limited
02.2010 - 07.2011

Team Leader

Accenture Services Pvt. Ltd
01.2009 - 01.2010

Medical Associate

Medicare TPA (I) Pvt. Ltd
12.2007 - 08.2008

In-Charge, Critical Care Unit

Sonoscan Hospital Pvt. Ltd
02.2006 - 07.2006

Attending Doctor, Critical Care Unit

Peerless Hospital & B.K. Roy Research Centre
05.2005 - 06.2006

Resident Medical Officer, Dept. of TB and Chest

M.R. Bangur Hospital
01.2002 - 10.2003

MBBS - Internal Medicine

Calcutta University

PGDHA - Hospital administration

Apollo Hospital Education And Research Foundation

certificate course in “Pharmacovigilance & Pharmacoepidemiology - Pharmacovigilance

SYMOGEN INDIA

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Aniruddha Bhattacharyya