Kumar Kapinjal Dev
Assistant Manager (PSRM)
Bengaluru
Summary
- Seeking assignments in life science & healthcare domain with an organization of repute.
- Offering 8.2 years of experiences in Pharmacovigilance out of which 5 years of experience in case processing along with QC role with a high degree of accuracy.
- Literature searches in global biomedical databases (e.g., Embase, PubMed) for ICSR identification. Assessing/ reviewing for combination products.
- Analyzing ICSR forms, case assessment, triage, data entry and quality review. Rejection QC.
- Experienced in quality support activities including Quality trend analysis, RCA and CAPA management.
Overview
9
9
years of professional experience
4
4
Languages
Work History
Assistant Manager
Viatris
12.2020 - Current
- To assist the Manager, PV Operations/ designee in executing the PV activities pertaining to case triage and case processing regarding Global PV requirements and as per existing regulations.
- Perform the duplicate check, Book-in, triage, data entry of ICSRs into the Global Safety Database in stipulated timelines in accordance with Mylan quality standards and in accordance with international regulatory requirements.
- Assist the Global PSRM in various PV related activities.
- Assisting trainee associates with project specific on-job trainings and procedures.
- Perform literature screening in Pubmed for combination products.
- Perform literature screening in Pubmed for potential company suspect drugs and associated adverse drugs reactions.
- Managing Vendor for ICSR activities and primary point of contact for the project (Global Literature).
- Oversight internal triage, data entry and quality review activities.
- Rejection QC of the incoming processed E2b files.
- Follow-up activities for cases/ queries with health/ non-healthcare professionals, authors of the articles.
- Necessary interact with the Business development department to deliver information on drug safety etc.
- Late case investigations along with support activities including Quality trend analysis, RCA and CAPA management.
Senior Associate
Norwich Clinical Services Pvt. Ltd
08.2019 - 08.2020
- Initial assessment of the case, case triage as per the internal procedures.
- Data entry and Quality check of the safety information in the database.
- Data entry and tracking of assigned drug information, line listings and medical information reports into tools.
- Coding of products as per the company product reference document.
- Writing safety narratives and company narratives as per the cases.
- Global literature search.
- Medical literature monitoring (MLM).
- E2B file imports into safety Database.
- Follow-up activities for cases/ queries with MAH, health/ non-healthcare professionals.
- Reconciliation of cases.
- Closure and deletion of cases and administrative edits.
- Query management with vendors.
- Preparation of data for the internal project review meetings/ minutes of meetings (MOMs').
- Creation and maintenance of project specific files/trackers/spreadsheets.
- Assisting mentee with project specific on-job trainings and procedures.
Trainee Junior Data Analyst
Cognizant Technology Solutions
06.2017 - 12.2018
- Recording and reporting of adverse reactions received from regulatory authorities, healthcare professionals and consumers for both drugs and vaccines.
- Initial assessment of the case, case validity and listedness as per the guidance documents.
- Coding of products as per the company product dictionary (CPD)/WHO-DD.
- Coding of indications, medical history/ underlying conditions and events as per MedDRA.
- Writing safety narratives and company narratives as per the case seriousness.
- Creation and maintenance of project specific files.
- Follow-up activities with authors, HCPs and non-HCPs' regarding missing case information.
Education
Bachelor of Pharmacy -
Assam University, Silchar
Assam01-2015
Master of Pharmacy - Pharmaceutics
Gupta College of Technological Sciences, Asansol
West Bengal01-2017
Skills
- Technically comprehensive
- Strong and consistent
- Ability of multitasking
- Adaptability and flexibility
- Workload management
- Vendor relationship management
- Compliance
- Multitasking
- Self motivation
- Problem-solving aptitude
- Work Planning and Prioritization
Interests
Photography
Music
Community Outreach Organizer
Organizing Reading Days
Animal rescue
DIY crafts
Personal Information
- Date of Birth: 3rd November 1992
- Place: Silchar, Assam
- Marital Status: Married
- Availability: Bangalore, Hyderabad, anywhere in India
Trainings Attended
- Successfully completed training on Business Etiquettes, Email Writing & Conference call Etiquettes.
- Successfully completed training on effective communication, time management, diversity training.
Social Contacts - Linkedin
https://www.linkedin.com/in/kapinjal-dev-aa991266/
Timeline
Assistant Manager
Viatris
12.2020 - Current
Senior Associate
Norwich Clinical Services Pvt. Ltd
08.2019 - 08.2020
Trainee Junior Data Analyst
Cognizant Technology Solutions
06.2017 - 12.2018
Bachelor of Pharmacy -
Assam University, Silchar
Master of Pharmacy - Pharmaceutics
Gupta College of Technological Sciences, Asansol