SANKHADEEP BHOWMIK
Senior Safety Science Specialist
Bengaluru,KA
Summary
A seasoned professional with 6.8 years of comprehensive experience in pharmacovigilance operations, offering a diverse skill set tailored to the dynamic realm of drug safety and regulatory compliance. Adept at overseeing end-to-end pharmacovigilance processes within the CRO industry, ensuring meticulous adherence to the highest standards of quality and regulatory mandates. Proficient in both waterfall and agile project management methodologies, excelling in steering projects towards successful outcomes. Possess a strong foundation in data analytics, Excel proficiency, and automation, enhancing operational efficiency and decision-making capabilities. Eager to leverage this unique blend of experience and aspirations to drive impactful projects and collaborations within the clinical research landscape.
Overview
7
7
years of professional experience
6
6
years of post-secondary education
4
4
Certifications
3
3
Languages
Work History
Senior Safety Science Specialist
Fortrea Development
7 2021 - Current
- Managed safety data and adverse event reporting for clinical trials, ensuring timely submission of safety reports (SUSAR/PSUR) to regulatory authorities/IRB/Investigators.
- Monitored and managed submission workflows for various studies, prioritizing and delegating tasks among team members to meet internal and regulatory timelines.
- Supported Project Manager/Project Safety Lead/Line Manager to maintain project audit readiness.
- Collaborated with internal and external stakeholders to communicate drug safety-related information effectively.
- Contributed to the development and delivery of safety training programs for employees and external partners.
- Monitored and analyzed safety trends and metrics, identifying areas for improvement and implementing risk management strategies.
- Collaborated with cross-functional teams for assigned clinical studies, including SMP preparation/review, protocol review, IB review, SAE/SUSAR review, and safety sections of periodic safety reports.
- Assisted Project Managers in developing SOPs, working guidance, and ensuring pharmacovigilance compliance.
Senior Drug Safety Associate
Bioclinica Safety And Regulatory Solutions
02.2019 - 07.2021
- Reviewed and assessed safety data from clinical trials and post-marketing sources for completeness and accuracy, including case validity, seriousness, handling CPD/WHO-DD, MedDRA, causality assessment, and labelling as per CCDS, USPI, SmPC.
- Acted as a subject expert, providing support to the ICSR team in resolving queries on the floor.
- Assisted in preparing meeting agendas and MOM for weekly client meetings, addressing feedback from the client based on the preceding week's reports.
- Conducted regular team huddles to discuss errors or findings from the client, soliciting advice on resolving ongoing error trends, and updating the team on work-related updates.
- Served as a project trainer, mentoring both junior and experienced drug safety associates and facilitating their transition into the production environment.
- Provided drug safety expertise and guidance to internal and external stakeholders.
- Collaborated with cross-functional teams to ensure compliance with regulatory requirements.
- Participated in safety audits and inspections, ensuring adherence to internal and external standards.
Drug Safety Associate
Bioclinica Safety And Regulatory Solutions
05.2017 - 02.2019
- Conducted processing and safety reviews of adverse event reports for all types of individual case safety reports (ICSRs include spontaneous, solicited, clinical trial, and Patient Assistance Program (PAP) and literature cases) in the safety database (both Argus and Arisg), ensuring compliance with regulatory requirements.
- Collaborated with cross-functional teams to identify and evaluate potential safety concerns and ensure accurate reporting of safety data to regulatory agencies.
- Maintained knowledge of relevant regulations, guidelines, and industry best practices related to drug safety.
- Provided support for safety-related inquiries from internal and external stakeholders.
- Maintained and updated safety databases and tracking systems.
- Provided training and support to other team members on drug safety processes and regulations.
Education
Master of Science - Pharmacology And Toxicology
JSS College of Pharmacy
Ooty 05.2015 - 05.2017
Bachelor of Science - Pharmacy
JSS College of Pharmacy
Ooty 05.2011 - 05.2015
Skills
Microsoft Excel proficiency (including Automation)
Data Analytics
Training and mentoring
Teamwork and Collaboration
Flexible and Adaptable
Excellent Communication
Critical Thinking
Problem-Solving
Project Management
Accomplishments
- Appointed as project trainer, leading the development of a high-performing training team focused on achieving results.
- Received rewards and recognition from key stakeholders for exceptional performance and contributions.
- Implemented innovative ideas to enhance project professionalism and client/staff interactions.
- Drove improvements in project performance, productivity, and cost-effectiveness through strategic initiatives.
- Demonstrated consistent excellence in delivering outstanding results to clients, even during challenging circumstances such as service disruptions, organizational changes, and staffing issues, contributing significantly to team objectives and critical outcomes.
Certification
Certification in Google Project Management, and Agile project management (Certificate URL: https://www.credly.com/badges/2fedd9de-cb46-4663-a148-00e52da8543c/linked_in_profile)
Timeline
Senior Drug Safety Associate
Bioclinica Safety And Regulatory Solutions
02.2019 - 07.2021
Drug Safety Associate
Bioclinica Safety And Regulatory Solutions
05.2017 - 02.2019
Master of Science - Pharmacology And Toxicology
JSS College of Pharmacy
05.2015 - 05.2017
Bachelor of Science - Pharmacy
JSS College of Pharmacy
05.2011 - 05.2015
Senior Safety Science Specialist
Fortrea Development
7 2021 - Current