Pratap Dakua
Pharmacovigilance And Drug Safety
Mumbai,MH
Summary
Experienced Pharmacovigilance and Clinical Adjudication Coordinator with over 6.5 years of experience in Pharmacovigilance and Drug Safety. Excellent reputation for resolving problems and improving customer satisfaction. Professional processing expert prepared to bring high level of precision and efficiency to new role. History of optimizing workflow and ensuring accuracy of data management, contributing to improved operational outcomes. Known for effective collaboration and adaptability to meet evolving business needs, showcasing strong analytical and organizational skills.
Overview
11
11
years of professional experience
Work History
Clinical Adjudication Coordinator
LabCorp Drug Development (Covance India Pharmaceuticals Ltd.)
Bengaluru, Karnataka
01.2020 - Current
- Organization: LabCorp Drug Development.
- Role: Clinical Adjudication Coordinator.
- Working as Clinical Adjudicator.
Case Processing Specialist
Abbott
Mumbai, Maharashtra
06.2023 - Current
- Contributed to team success by consistently meeting or exceeding productivity targets and quality standards.
- Maintained high levels of accuracy throughout daily tasks, resulting in a strong track record of minimal errors or rework required.
- Assisted in the development of training materials for new hires, facilitating a smooth onboarding experience for incoming team members.
- Participated in regular departmental meetings, contributing valuable insights towards streamlining operations and improving team performance.
Senior Process Associate
Tata Consultancy Services, TCS
Mumbai, Maharashtra
04.2017 - 01.2020
- Worked as patient safety specialist+.
Junior Data Analyst
Cognizant Technology Solutions
Mumbai
10.2015 - 04.2017
- Worked as Junior Data Analyst in Oncology Department of Drug Safety.
Education
M. Pharmacy - Pharmacology
Nirma University
08.2013 - 07.2015
B. Pharmacy -
Biju Patnaik University Of Technology
08.2009 - 07.2013
Skills
Six years of Experience in Case processing and Case quality review in ARGUS safety database, Sapphire Database and IBM Clinical Database
Worked as a Quality reviewer and worked with KPI team Prepare and monitor productivity and quality metrics of employees Maintains and tracking of employee absence tracker and training compliance report
Processed both E2B and non-E2B cases, clinical trial cases (oncology), PMS cases (oncology), compassionate cases, Spontaneous cases, Legal cases, SUSAR cases and oncology cases
Monitoring queries from stake holders, trial sites, licensing partner
Draft RCA and CAPA for project Prepare RCA and CAPA for late cases, Key field errors, process error etc
Mentoring and Train junior associates
Prioritize ICSR according to regulatory requirements and tracking of pharmacovigilance database
Enters data into the safety database/adjudication database in accordance with sponsor specific guidelines and company standards
Data correction, data amendment in safety database Unblinding of study drug in SUSAR cases
Good knowledge on GVP I, GVP II, GVP III, GVP IV, GVP V, GVP VI, GVP VII, GVP VIII, GVP IX, GVP X Guidelines Good knowledge on E2A, E2B, E2C, E2D, E2E and E2F Guidelines
Maintaining event tracking system, event case processing, intake and triage, event linking, event deactivation, tracking, data entry, document processing (redaction of specified content)
Coordinate implementation of adjudicator workflows Implementation of adjudicator disagreement resolution process, implementation of re-review and re-adjudication process, processing adjudicator request for additional documentation Processing of adjudicator notifications of potential unreported events
Provide mentoring and quality control for less experienced adjudication service staff, as appropriate
Additional Information
- ACCOMPLISHMENTS: People Excellence Award for managing the high workload, BPS Star Performer Award in Appreciation of outstanding contribution to the organization for dedication and commitment and being an inspiring role model to colleagues.
- Superstar Team Award in Year One Academy- BPS for exhibiting exemplary performance during the skill enhancement program.
OTHER KEY RELEVANT SKILLS:
· ARGUS Database, Sapphire Database, EudraVigilance (Only importing), BOB application, IBM Clinical Database and RAVE Database.
· Knowledge of coding principles, submission criteria and regulatory reporting requirements.
· Proficient in MS Office suite and good IT skills. Knowledge of Argus case workflow monitoring.
PROJECTS:
· “Effects of Oryzanol, Ketone body and L-Arginine on transient middle cerebral artery occlusion induced stroke.”
· “A retrospective drug utilization study in acute lymphoblastic leukaemia.”
SEMINARS ATTENDED/POSTERS PRESENTED:
· Presented a Poster at National Conference of Institute of Pharmacy, January 22nd – 23th 2015.
· Presented a Poster at International Society for Heart Research, NIPER, Mohali, February 8-9, 2014.
· Presented a Poster at Nirma Institute of Pharmacy International Conference, January 23-25, 2014.
· Presented a Poster in National Seminar-2013 at Puri.
· Presented a Poster at 64th IPC 2012 at Chennai.
Timeline
Case Processing Specialist
Abbott
06.2023 - Current
Clinical Adjudication Coordinator
LabCorp Drug Development (Covance India Pharmaceuticals Ltd.)
01.2020 - Current
Senior Process Associate
Tata Consultancy Services, TCS
04.2017 - 01.2020
Junior Data Analyst
Cognizant Technology Solutions
10.2015 - 04.2017
M. Pharmacy - Pharmacology
Nirma University
08.2013 - 07.2015
B. Pharmacy -
Biju Patnaik University Of Technology
08.2009 - 07.2013