Harshitha
Pharmacovigilance Professional
- Role
- Drug Safety Associate at IQVIA India
- Location
- Kochi, KL, IN
- LinkedIn followers
- 500 followers
About Harshitha
With over a year of experience in pharmacovigilance, I’ve built a strong foundation in drug safety operations and regulatory compliance. My work has spanned multiple case types and therapeutic areas, giving me a well-rounded understanding of global PV practices. End-to-end ICSR processing across spontaneous, solicited, and clinical trial sources Hands-on experience with medical device safety coding and MedDRA terminology Proficient in triage, seriousness assessment, and regulatory reporting workflowsStrong understanding of global PV guidelines and compliance standards Collaborative team player with a focus on quality, timelines, and continuous learningContinue growing in the pharmaceutical domain through upskilling and cross-functional exposure who’s detail-oriented, adaptable, and ready to take on new challenges in regulatory or clinical operations!
Experience
Drug Safety Associate
Aug 2024 — Present · Kochi, IN
Individual Case safety Reports(ICSRs)Processing of all types of case reports (spontaneous, clinical trail, aggregate data, interventional & non- interventional study cases) Proficient use & coding using MedDRA 28.0 version Interpreting & accessing causality & expectedness of adverse events Writing medically sound case narrative in chronological order in Newsletter and filling E2B forms, with consistency, respective conventions & accuracy with the source document received Worked on ICSR of different therapeutic area including cardiovascular, anti-cancer, immunological drugs Experienced in medical device coding of combination products Demonstrated consistent accuracy and efficiency in triage activities, including prioritization of cases based on seriousness, source, and regulatory timelines Performing Quality checks for the cases processed & listing with the medical review team for the accuracy & correctness of the data captured in safety database within stipulated time as per the customer guidelines and SOPs Completing assigned trainings other tasks on time and familiar with databases like Arisg, LSMV, Veeva vault, etc.
Education
Sevenhills college of pharmacy
Bachelors of pharmacy , Pharmacy
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