Argus Database
Debopriyo Pradip Ray
Pune
Summary
Recognized as a leader leveraging an in-depth knowledge of delivery and technical expertise in pharmacovigilance and operation efficiency. Accomplished pharmacovigilance professional with 15 years of experience in the pharmaceutical industry. Consistently demonstrated a proven track record of effectively managing pharmacovigilance operations, leading cross-functional teams, and ensuring compliance with global regulatory requirements. Strength lies in ability to bridge performance gaps to complete business interests, develop process improvement initiatives, and convey complex concepts simply and compellingly. Currently seeking a management position in clinical research, bringing years of valuable experience to contribute to the success of the organization.
Overview
17
17
years of professional experience
5
5
Certifications
4
4
Languages
Work History
Delivery Manager, Patient Safety Solutions
Fortrea
10.2021 - Current
- Company Overview: Formerly Labcorp, Covance, Sciformix
- Standardized and enhanced operational processes to ensure timely project deliverables.
- Led RFI, RFP, and bid defense discussions to secure new business opportunities.
- Ensured regulatory compliance across pharmacovigilance operations.
- Cultivated a customer-centric approach, driving high-quality service delivery.
- Allocated resources efficiently and delegated responsibilities effectively.
- Managed project scope, risks, and day-to-day operational requirements.
- Spearheaded process and productivity improvements for enhanced efficiency.
- Conducted engagement reviews and quality assurance assessments.
- Maintained accurate and updated project documentation.
- Resolved operational issues promptly, escalating when necessary.
- Supervised Medical Contact Centers in the Philippines and Canada.
- Led a team of translators for multilingual project requirements.
- Oversaw vendor management for translation and QPPV services.
- Directed proposal development, project scoping, and cost estimation.
- Conducted financial analysis, evaluating profitability, margins, and utilization.
Sr. Manager, Patient Safety Solutions
Fortrea
10.2020 - 09.2021
- Ensured regulatory compliance in pharmacovigilance operations.
- Promoted a culture of service excellence and customer satisfaction.
- Managed SLA adherence and service delivery optimization.
- Developed and executed project work plans in alignment with business needs.
- Conducted budget and financial management for project success.
Project Manager, Patient Safety Solutions
Fortrea
07.2018 - 09.2020
- Ensured delivery of services meets or exceeds Service Level Agreements
- Created and executed project work plans and revised as appropriate to meet changing needs
- Prepared for engagement reviews and quality assurance procedures
- Ensured project documents are complete, current, and stored appropriately
- Resolved and/or escalated issues in a timely fashion
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Planned, designed, and scheduled phases for large projects.
- Identified plans and resources required to meet project goals and objectives.
- Monitored project performance to identify areas of improvement and make adjustments.
General Manager, Pharmacovigilance
Spectrum Pharmaceutical Inc
07.2013 - 08.2018
- Managed day-to-day operations in a specific part of the process for drug safety (combination of Case Entry, Medical Coding, Safety Narrative Writing, QC)
- Proactively identified and supported the initiatives focused on the quality system, processes, and compliance improvements
- Hired and recruited resources and effort estimations
- Vendor Management
- Cultivated strong relationships with clients, vendors, and partners to ensure long-term success and loyalty.
- Monitored financial performance, set budgets and controlled expenses to provide financial stability and long-term organizational growth.
- Managed budget implementations, employee reviews, training, schedules, and contract negotiations.
- Implemented effective cost-saving measures to reduce overhead expenses without compromising quality or service.
Team Leader, Pharmacovigilance
Cognizant Technology Solution
10.2012 - 07.2013
- Project lead for SAE reconciliation and responsible for overall delivery of project milestones
- Led team for PVG and was responsible for case distribution, case tracking and quality check and ensured high-quality output of the team
- Monitored quality and efficiency across functions to identify trends and opportunities for improvements
- Trained and mentored new associates
- Monitored workload and appropriate allocation of resources
- Provided training in safety monitoring and regulatory obligations
- Quality check of safety data reconciliation
- Provided inputs to the Project Manager on resource requirements, challenges in terms of timelines/SLAs, and client escalations
- Provided guidance supervision and feedback to the direct reports for assigned projects and performed appraisals
Safety Data Manager II
Pharmanet i3
11.2009 - 10.2012
- Case processing, narrative writing, preparation and submission of 7-day and 15-day expedited/non-expedited safety reports to regulatory authorities, Quality review of cases
- Responsible for safety data reconciliation
- Quality check of clinical and safety database as part of the reconciliation
- Liaison with Clinical Operations, Data Management, PVG team and Medical Coding teams to ensure reconciliation within stipulated timelines
- Maintained case tracking
- Trained and mentored new associates
Drug Safety Associate
Tata Consultancy Services
06.2008 - 10.2009
- Provided comment to DSS/PSSR team, in case of data corrections and errors
- Managed Safety Data Pharmacovigilance Detection and reporting of suspected ADRs and other drug-related problems
- Initial data entry of case reports into the safety database and assessment of case reports for seriousness, causality and expectedness
- Narrative writing, prepared and submitted of 7-day and 15-day expedited/non-expedited reports to regulatory authorities, labelling for expectedness as per company causality
- Completed analysis of adverse events concerning causality, identified clinically relevant information missing from the case report and facilitated correction
- Preparation of patient safety report for reporting to health regulatory authorities, Co-ordinated with the client for resolution of priority cases
- Used medical dictionaries and guidelines to code medical history, drugs and adverse event terms
- Prepared narrative summarizing the essential details of the case
- SUSAR identification and coding
- Processed Spontaneous reports, Licensee cases, Clinical cases
- Updated query/resolution database on a regular basis
Education
MBA - Operation Management
Welingkar Institute of Management
Mumbai 04.2001 -
Bachelor of Pharmacy - Pharmacy
Bharati Vidyapeeth's Collage Of Pharmany
Mumbai 04.2001 -
High School Diploma - Science
Kendriya Vidyalaya Saltlake No 1
Kolkata 04.2001 -
Skills
- Pharmacovigilance Operations Management
- Project Management
- Regulatory Affairs (ICH Guidelines)
- Budget Management
- Risk Management
- Team Leadership and Development
Delivery management
Continuous delivery
Team supervision
Effective communication
Certification
Six Sigma Green Belt & Black Belt
Software
ArisG (LSMV)
ADVENT
Oracle Clinical Database (e-CTD)
Timeline
Delivery Manager, Patient Safety Solutions
Fortrea
10.2021 - Current
Sr. Manager, Patient Safety Solutions
Fortrea
10.2020 - 09.2021
Project Manager, Patient Safety Solutions
Fortrea
07.2018 - 09.2020
General Manager, Pharmacovigilance
Spectrum Pharmaceutical Inc
07.2013 - 08.2018
Team Leader, Pharmacovigilance
Cognizant Technology Solution
10.2012 - 07.2013
Safety Data Manager II
Pharmanet i3
11.2009 - 10.2012
Drug Safety Associate
Tata Consultancy Services
06.2008 - 10.2009
MBA - Operation Management
Welingkar Institute of Management
04.2001 -
Bachelor of Pharmacy - Pharmacy
Bharati Vidyapeeth's Collage Of Pharmany
04.2001 -
High School Diploma - Science
Kendriya Vidyalaya Saltlake No 1
04.2001 -
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