Pravriti Mehta
Senior Drug Safety Associate
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About
Results-driven Pharmacovigilance professional with nearly 9 years of experience in ICSR case processing, safety data management, quality control, regulatory compliance, literature cases, narratives and follow-up activities. Experienced in independently managing deliverables, leading project activities, QC review, mentoring and training team members, and delivering high-quality work within demanding timelines. Demonstrated ability to work independently, learn new processes quickly, take ownership, and adapt to new roles and responsibilities.
Open to broader opportunities within Pharmacovigilance and Drug Safety.
Experience
Senior Drug Safety Associate at EVERSANA (2024-07 – Present)
- Perform duplicate checks, data entry, case classification, amendments and follow-ups, including patient, reporter, medical history, laboratory, drug, dosing and device information.
- Assess and document seriousness, onset, duration, outcomes, event ranking, causality and expectedness in accordance with applicable requirements.
- Author and update high-quality case narratives and maintain contact logs, workflow comments and follow-up activities.
- Apply MedDRA and WHODrug Global for accurate and consistent safety data coding.
Safety Associate at IQVIA (2018 – 2024-07)
- Processed safety cases while ensuring PHI redaction, data privacy, accuracy, completeness and adherence to project KPIs and timelines.
- Managed duplicate checks, amendments, follow-up information and case queries for missing or unclear data; contacted sites for required clarifications.
- Authored high-quality narratives and processed literature cases while consistently meeting productivity, quality and turnaround-time expectations.
- Performed case quality control (QC) reviews and supported maintenance of consistently high-quality case outputs.
- Generated regulatory reports, supported reconciliation activities and tracked case-processing metrics.
- Led an assigned project independently for approximately six months, taking ownership of project activities and deliverables and ensuring completion ahead of deadline with no reported errors.
- Mentored and trained new team members on project processes, case-processing requirements, quality expectations and day-to-day workflow activities.
- Provided additional support during critical periods, including extended hours and weekends when required, to ensure business-critical targets and deliverables were met.
Production Officer at Acme Solutions (2017-07 – 2017-12)
- Prepared material requisitions for batch dispensing, monitored production processes and supported manufacturing activities.
- Ensured adherence to safety standards and reviewed batch manufacturing records for completeness and compliance.
Apprentice, Production Department at Sentiss Manufacturing Plant (2016-04 – 2017-04)
- Supported ophthalmic product manufacturing activities, including operation of autoclave and filtration systems.
- Performed disinfectant preparation, filter integrity testing and product sterilization activities in accordance with manufacturing procedures.
Education
Bachelor of Pharmacy – Dayanand Sagar College, Rajiv Gandhi University of Health Sciences (2011 – 2015)