Argus Safety
Arun Teja Nadiminti
Pharmacovigilance Associate
Hyderabad,Telangana
Summary
Experienced Pharmacovigilance Associate with over 1 year and 8 months of experience in Pharmacovigilance. Excellent reputation for achieving daily productivity with high quality. Dedicated PV professional with history of meeting company goals, assigned duties in timelines utilizing consistent and organized practices. Leverages scientific approach to multi-task, achieve targets and integrate new ideas within existing processes. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. Clear understanding of procedures and training in . Motivated to learn, grow and excel in Pharmacovigilance.
Overview
2
2
years of professional experience
5
5
years of post-secondary education
Work History
Pharmacovigilance Associate
Aspen Pharmacare
Hyderabad, Telangana
03.2021 - Current
- End-to-end processing of ICSRs in Literature, Spontaneous and Regulatory cases with a focus on submission processes in Argus Safety Database 8.4.
- Expertise in Data entry of ICSRs and processing of serious and non-serious Adverse events reports.
- Performing appropriate clinical assessments of seriousness, labeling and company causality for adverse events and adhering to regulatory requirements (good pharmacovigilance practices (GVP)).
- Oversight of ICSR submission-related activities including retrospective review of ICSR submissions, manual submissions and cross-checking automated submissions in the Argus Safety Database.
- Monitored deliverables for quality and adherence to regulatory reporting timelines.
- Trained staff for data entry.
- Supported inspections, visits and audits as well as CAPAs management.
- Developed new and improved pharmacovigilance procedures complying with company regulations.
- Reviewed, compiled and analyzed data for safety database management.
- Responded to requests from regulatory agencies and notified to share information.
- Oversaw adverse events case reporting and conducted follow-up.
- Reported problems and concerns to management.
Education
Professional Doctorate - Pharmaceutical Sciences
Annamacharya College of Pharmacy
Rajampeta 10.2014 - 03.2020
Skills
Data interpretation
Software
Timeline
Pharmacovigilance Associate
Aspen Pharmacare
03.2021 - Current
Professional Doctorate - Pharmaceutical Sciences
Annamacharya College of Pharmacy
10.2014 - 03.2020
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