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Debolina Sarma Roy

Senior Pharmacovigilance Associate

Bengaluru

8+ years of work experience

Teva Pharmaceuticals
Sep 20241 yr 9 mosPresent

Bengaluru, Karnataka, India

Syneos Health
Oct 20221 yr 11 mosAug 2024

Hyderabad, Telangana, India

• Responsible for case triage and case processing of the incoming Adverse Events (AEs)/ safety information and review of potential complaint data. • Ensuring the processes, procedures, and systems are in place for case intake, data entry, conducting follow up, translating and reconciling adverse events and other safety information reportable to regulatory authorities from various sources including but not limited to spontaneous, solicited sources and from clinical studies. • Worked closely with affiliate officers for various countries and was responsible for ensuring follow up activities are carried out to respective PSP programs, HCP offices and consumers properly according to country legislation. • Worked on eTMF Veeva Vault for maintaining various clinical documents, SOPs and reconciliation documents related to the process and ensures all the activities are carried out according to protocols. • Provided trainings to fresh staff and conducted team meeting to ensure the processes are in accordance with SOPs. • Receiving complaints from the sources; capturing accurate data and verbal follow-up for product complaints. • Taking follow up calls with respective point of contact (POC) for any query related to triage, quality complaints, adverse events, and any other relevant information. • Quality review of cases to check complete medical cohesiveness of the narrative and different data fields. • Strictly followed case submission timelines to meet the regulatory requirements.
Cognizant
Feb 20202 yrs 9 mosOct 2022

Kolkata, West Bengal, India

• Worked on registration, case triage, data processing and quality review of all types of cases including spontaneous, PMS, literature, clinical trials and E2B health regulatory authority cases such as MIC cases, EVHuman, GB MHRA, Health Canada on Argus. • Responsible for coding of medical history, adverse events, drugs / procedures / indications, and laboratory tests according to the appropriate dictionary (e.g., MedDRA, Company Product Dictionary, WHO-DD • Worked on reconciliation activities • Worked with leadership team for creating different metrics reports. • Ensured compliance with Global regulatory requirements and guidelines. • Provided training and guidance to the team members on pharmacovigilance processes and best practices. • Participated in various internal and regulatory audits. • Well versed with GVP modules and guidelines. • Good understanding of company policies and procedures.
Cognizant
Oct 20181 yr 5 mosFeb 2020

Kolkata, West Bengal, India

Education

Assam University

B. PHARM, Pharmacy

Assam University

20144 yrs2018

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Headline

Senior Pharmacovigilance Associate

About

Dedicated Senior Pharmacovigilance Specialist with a proven track record in ensuring patient safety through expert Patient Safety Reporting. Adept in implementing and maintaining rigorous Quality Control measures, ensuring adherence to regulatory compliance standards. My expertise extends to comprehensive Quality Assurance practices, contributing to the seamless execution of pharmacovigilance processes. With a keen understanding of regulatory affairs, I navigate the dynamic landscape to ensure that our practices align with the latest industry standards. Committed to excellence in pharmacovigilance, I bring a wealth of experience and strategic insight to drive optimal outcomes in drug safety.

Location

Bengaluru

Work experience

Senior Pharmacovigilance Professional at Teva Pharmaceuticals, Sep 2024 - Present · 1 yr 9 mos, Bengaluru, Karnataka, India

PV and Safety Specialist I at Syneos Health, Oct 2022 - Aug 2024 · 1 yr 11 mos, Hyderabad, Telangana, India, • Responsible for case triage and case processing of the incoming Adverse Events (AEs)/ safety information and review of potential complaint data. • Ensuring the processes, procedures, and systems are in place for case intake, data entry, conducting follow up, translating and reconciling adverse events and other safety information reportable to regulatory authorities from various sources including but not limited to spontaneous, solicited sources and from clinical studies. • Worked closely with affiliate officers for various countries and was responsible for ensuring follow up activities are carried out to respective PSP programs, HCP offices and consumers properly according to country legislation. • Worked on eTMF Veeva Vault for maintaining various clinical documents, SOPs and reconciliation documents related to the process and ensures all the activities are carried out according to protocols. • Provided trainings to fresh staff and conducted team meeting to ensure the processes are in accordance with SOPs. • Receiving complaints from the sources; capturing accurate data and verbal follow-up for product complaints. • Taking follow up calls with respective point of contact (POC) for any query related to triage, quality complaints, adverse events, and any other relevant information. • Quality review of cases to check complete medical cohesiveness of the narrative and different data fields. • Strictly followed case submission timelines to meet the regulatory requirements.

Junior Data Analyst at Cognizant, Feb 2020 - Oct 2022 · 2 yrs 9 mos, Kolkata, West Bengal, India, • Worked on registration, case triage, data processing and quality review of all types of cases including spontaneous, PMS, literature, clinical trials and E2B health regulatory authority cases such as MIC cases, EVHuman, GB MHRA, Health Canada on Argus. • Responsible for coding of medical history, adverse events, drugs / procedures / indications, and laboratory tests according to the appropriate dictionary (e.g., MedDRA, Company Product Dictionary, WHO-DD • Worked on reconciliation activities • Worked with leadership team for creating different metrics reports. • Ensured compliance with Global regulatory requirements and guidelines. • Provided training and guidance to the team members on pharmacovigilance processes and best practices. • Participated in various internal and regulatory audits. • Well versed with GVP modules and guidelines. • Good understanding of company policies and procedures.

Trainee Junior Data Analyst at Cognizant, Oct 2018 - Feb 2020 · 1 yr 5 mos, Kolkata, West Bengal, India

Education

B. PHARM, Pharmacy, Assam University