Psychedelic innovation for global healing
Amit Kumar
Drug Safety
Fatehabad
Summary
Dedicated and detail-oriented Senior Drug Safety Associate with a strong foundation in pharmacovigilance and regulatory compliance. Possesses 4 years of experience in monitoring and assessing adverse event reports, collaborating with cross-functional teams, and ensuring the safety and well-being of patients. Adept at conducting comprehensive safety evaluations, contributing to risk management strategies, and maintaining accurate and compliant documentation. Proven track record of effectively navigating complex regulatory frameworks and guidelines to support drug safety initiatives. Seeking an opportunity to apply my expertise and contribute to a dynamic healthcare environment focused on patient safety and regulatory excellence.
Overview
12
12
years of professional experience
6
6
years of post-secondary education
4
4
Languages
Work History
Senior Drug Safety Associate
Bioclinica India Pvt Ltd
Mysore
11.2021 - 08.2022
- Receive, review and process SAE and /Adverse event reports from various sources on time and quality standards
- Accountable for sending queries for clarity associated with incoming information if required
- Accountable for performing accurate data capture for individual case safety reports which can be spontaneous and PMS cases
- Coding terms, as appropriate
- Ensuring reports are sent to client (submission in client database) within agreed timelines; updating narratives when updated information is received, as appropriate; liaising with client, executing case closure, and reconciliation
- Identifying suspect product following receipt of report; identifying reporting sources; and assessing reportability and expectedness of events
- Prioritize cases according to regulatory and project/client requirements
- Identify and record quality problems and bring them to attention of Senior Team
- Members and Line Managers
- Do root cause of errors and understand corrections required for cases not accurately data based
- Review and respond to e-mails after discussion with mentors/as appropriate and attend all appropriate meetings
- Complete all trackers applicable in process
- Attend and complete all trainings (internal and client) within specified timeline
- Ensure integrity and completeness of data according to applicable regulations and guidelines, SOPs and project-specific guidelines
- Mentor to less experienced/new staff members
- Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive work flow management.
Drug Safety Associate
Wipro
New Delhi
08.2018 - 11.2021
- Processing Spontaneous/Solicited/Clinical trial cases
- Processing Adverse Event cases to ARGUS Safety database
- Coding of Drugs by CDD (Company Drug Dictionary) and WHO Drug Dictionary
- Preparation of SAE reports, which includes preparation of narrative summary, identifying missing/discrepant data, writing queries, addressing queries with site personnel, evaluating query response and resolving queries and case validation
- Filing PCs (product complaints) associated with adverse events
- Setting up follow-up letter to reporter for further follow-up as per applicable guidelines for required cases
- Analysis of AEM (Adverse Event Monitoring) Report Form
- Reviewing source document to assure relevant information pertaining to case is appropriately entered into database fields
- Reviewing and processing adverse event reports according to applicable regulations, guidelines, SOPs and project requirements within specified timelines by meeting quality standards
Exhibition Manager
Franchise India Holding Ltd
New Delhi
06.2016 - 12.2016
- Lead generation and bringing up new clients on board
- Revenue Generation
- Sourcing Barters and Sponsorships for various events (Liquor, Cabs, Hospitality
- Maximized performance by monitoring daily activities and mentoring team members
- Cross-trained existing employees to maximize team agility and performance
- Developed and maintained relationships with customers and suppliers through account development
- Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground
- Accomplished multiple tasks within established timeframes
- Maintained professional, organized, and safe environment for employees and patrons
- Communicated clearly with employees, suppliers and stakeholders to keep everyone on same page and working toward established business goals
- Improved marketing to attract new customers and promote business
- Developed and implemented business strategies to achieve business goals and stay competitive
Territory Manager
Economic Times
New Delhi
06.2011 - 01.2016
- Looking after the proper mapping of potential target audience and regularly approaching the CEO or Managing Directors with the relevant information through calling, mailing and regular follow-ups
- Managed over 20 accounts within North territory
- Attended trade shows and industry events to promote company products and services
- Worked with vendors and suppliers to support timely delivery of products and services
- Conducted regular market analysis to identify new opportunities for territory sales growth
- Implemented promotions and marketing campaigns to increase territory sales and brand awareness
- Cultivated relationships with key accounts in territory and provided support to drive customer satisfaction
- Planned and conducted weekly sales meetings to keep sales representatives up-to-date on new products and strategies
- Researched competitor activity and used findings to develop sales growth strategies
Medical Business Associate
Glaxo-Smithkline
New Delhi
10.2010 - 05.2011
- Handled products like Neosporin, Cefspan, Zyloric, etc.; sold the products to the doctors and patients prescribed the products
- Met stockiest and retailers for the availability of the products
- Prepared monthly reports along with an improvement plan; discussed the same with the senior management
- Took initiatives for improving the product sales through various schemes
- Achievements: Successfully incorporated the product called ‘LILO’ (Atorvastatin).
Education
Bachelor - Pharmacy
Kurukshetra University
Kurukshetra University 08.2006 - 07.2010
12th -
Kamla Montessori School
Sirsa, Haryana 04.2005 - 05.2006
10th -
Tagore Model School
Fatehabad, Haryana 04.2002 - 03.2003
Skills
Pharmacovigilance and Safety Reporting
undefinedInterests
Timeline
Senior Drug Safety Associate
Bioclinica India Pvt Ltd
11.2021 - 08.2022
Drug Safety Associate
Wipro
08.2018 - 11.2021
Exhibition Manager
Franchise India Holding Ltd
06.2016 - 12.2016
Territory Manager
Economic Times
06.2011 - 01.2016
Medical Business Associate
Glaxo-Smithkline
10.2010 - 05.2011
Bachelor - Pharmacy
Kurukshetra University
08.2006 - 07.2010
12th -
Kamla Montessori School
04.2005 - 05.2006
10th -
Tagore Model School
04.2002 - 03.2003
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