Sumit Sachdeva
Drug Safety Scientist II
Mysore
Summary
Accomplished Drug Safety Scientist with a proven track record at Qinecsa Solutions in enhancing drug safety protocols and mentoring teams for peak performance. Expert in Adverse Event Reporting, Patient Safety, People Management and Project Management, I've led initiatives that significantly improved data accuracy and efficiency. Skilled in fostering cross-functional collaborations and driving regulatory compliance, I excel in fast-paced environments, ensuring patient safety and project success.
Overview
9
9
years of professional experience
Work History
Drug Safety Scientist II
Qinecsa Solutions
01.2024 - Current
- Lead and manage the project
- Communicate between the team members and Project Manager
- Record, maintain and track the metrics for both team members and project performance
- Review and evaluate Adverse event case information to determine required action based on and following internal policies and procedures.
- Delegate tasks and responsibilities to appropriate personnel
- Act as guide, coach and counsellor for the team
- Overall monitoring of Service level agreement (SLA) and Standard operating procedure (SOP) compliance
- Corrective and Preventive action (CAPA) management
- Organizes periodic feedback sessions with the team members.
- Provides updates for process efficiency and compliance improvement updates
- Act as a workflow manager in ARGUS Safety
- Provide guidance for Data entry & Quality teams
- Identify and resolve issues and conflicts within the project team
- Oversee, mentor and guide the activities of the Drug Safety and Senior Drug Safety Associates.
Drug Safety Scientist I
Qinecsa Solutions
07.2022 - 12.2023
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures
- Follow-up on reconciliation discrepancies
- Train and mentor new team members as per requirements of the project
- CAPA management
- Supports SDM/DSOM in performing root cause analysis of failed cases
Drug Safety Scientist I
Bioclinica
01.2022 - 06.2022
- Act as a workflow manager in ARGUS Safety
- Organizes periodic feedback sessions with the team members
- Train and mentor new team members as per requirements of the project.
- Delegate tasks and responsibilities to appropriate personnel.
Senior Drug Safety Associate
Bioclinica
02.2020 - 12.2021
- Collaborated with cross-functional teams to develop effective risk mitigation strategies for newly identified safety concerns.
- Streamlined adverse event case management, leading to improved efficiency and accuracy in data analysis.
- Evaluated emerging trends in drug safety regulations, providing expert recommendations to senior management for strategic planning purposes.
- Established a strong professional network within the drug safety community, actively participating in industry conferences and events to stay abreast of emerging trends and advancements.
- Organizes periodic feedback sessions with the team members
- Supports PM in performing root cause analysis of failed cases
- Identify potential discrepancies in source document and initiate queries
- Identifying of Safety Data Exchange Agreement (SDEA) products and share the information to other organizations according to the agreement
- Product coding, Event Assessment, Seriousness criteria, Narrative Writing and conducting all follow-up activities as required in Argus Safety Database
- Data validation i.e. Cross-checking against source document and MedDRA coding in accordance with MedDRA term
- Quality control check of adverse event for accuracy and completeness
Pharmacovigilance Officer
Wipro BPS
08.2015 - 05.2018
- Attended personnel meetings and training sessions to improve skills and learn new policies and procedures.
- Established effective relationships with key stakeholders both internally and externally for increased collaboration opportunities.
- Mentored junior staff members, helping them develop their skills and advance in their careers.
- Prepared and submitted detailed reports regarding assignments and ongoing investigations.
- Data Entry in the Migration data entry workflow step in accordance with the report from mapping instructions
- Book-In/Initiation of ICSR’s into the safety database, conducting duplicate search prior to book-in so that potential duplicates can be identified and managing accordingly.
- Perform follow-ups and company notifications, LPs with the company
Education
M. Pharmacy - Pharmacology
Institute of Pharmaceutical Sciences
Kurukshetra, India 04.2001 -
B. Pharmacy - Pharmaceutical Sciences
PGIMS Rohtak
Rohtak, India 04.2001 -
Skills
Project Management
Timeline
Drug Safety Scientist II
Qinecsa Solutions
01.2024 - Current
Drug Safety Scientist I
Qinecsa Solutions
07.2022 - 12.2023
Drug Safety Scientist I
Bioclinica
01.2022 - 06.2022
Senior Drug Safety Associate
Bioclinica
02.2020 - 12.2021
Pharmacovigilance Officer
Wipro BPS
08.2015 - 05.2018
M. Pharmacy - Pharmacology
Institute of Pharmaceutical Sciences
04.2001 -
B. Pharmacy - Pharmaceutical Sciences
PGIMS Rohtak
04.2001 -
Similar Profiles
Sharmila BanerjeeSharmila Banerjee
Drug Safety Scientist I at Qinecsa SolutionsDrug Safety Scientist I at Qinecsa Solutions
Karthikeyan SKarthikeyan S
Drug Safety Scientist (Medical Information Call Centre) at Qinecsa SolutionsDrug Safety Scientist (Medical Information Call Centre) at Qinecsa Solutions
Arun MunusamyArun Munusamy
Senior IT Manager at Qinecsa SolutionsSenior IT Manager at Qinecsa Solutions
Suvam Sekhar SahooSuvam Sekhar Sahoo
Drug Safety Associate II at Qinecsa SolutionsDrug Safety Associate II at Qinecsa Solutions
Amruta Suresh KulkarniAmruta Suresh Kulkarni
Deputy Manager at AXIS BANK LTDDeputy Manager at AXIS BANK LTD