Chetan Tank
Drug safety associate
Talent
Sūrat, SuratMember since December 24, 2022
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About
I am team player who is charismatic and workaholic person. Along with this I have deep knowledge of pharmacovigilance department.
Experience
- Issue final review of cases. Quality check of SAEs, SUSARs, Non-serious ICSRs.
- Actively assist in the safety management activities for clinical trials.
- Efficiently perform project management activities including research tasks.
- Report eudravigilance in compliance with EV web and E2B (R3).
- Ensure and carry out submission tracker and comply with applicable working instruction and Standard operating procedures.
- Ensure timely coverage to the regulatory authorities.
- Prudently keep track of the Product Quality Complaints; also participate in preparing safety reports and maintain clinical databases.
- Manage and account to all queries of discrepancy in source document.
- Provide assistance, and conduct periodic PV training of new joiners and to other staff employees.
- Review literature articles and assess them and develop standard operating procedures; also own expertise in MedDRA coding.
Education
Master in pharmacy. Gujarat techmological university, Gujarat, India