Mayank
PV Assistant II Immediate joiner
- Role
- Pharmacovigilance Assistant at Elite Safety Sciences
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Mayank
Detail-oriented and proactive pharmacovigilance assistant in ICSR processing and…
Experience
Pharmacovigilance Assistant
Nov 2024 — Present
Processed over 800 post-marketing individual case safety reports (ICSRs), ensuring accurate data entry and compliance with global regulatory standards. • Managed ICSR processing across multiple regulatory regions, including the USA, Japan, Israel, Canada, and Italy, aligning case handling with region-specific submission timelines and reporting rules. • Authored and quality-checked 800+ case narratives, maintaining consistency with safety data elements and adhering to client-specific templates. • Ensured 100% on-time case data entry and narrative completion, meeting client-agreed service level agreements (SLAs) and regulatory deadlines. • Conducted global and local literature screening and review to identify potential ICSRs and safety-relevant information. • Reviewed and analyzed more than 60 medical and scientific articles daily from various therapeutic areas. • Evaluated articles for case validity, seriousness, and expectedness in alignment with regulatory requirements. • Prepared literature summaries and case assessments, ensuring data accuracy and compliance with global PV standards. • Managed ICSR processing across multiple regulatory regions, including the USA, Japan, Israel, Canada, and Italy, aligning case handling with region-specific submission timelines and reporting rules. • Utilized databases such as PubMed, Embase, and Ovid for literature search and assessment. • Verified MedDRA coding for all AEs/SAEs, maintaining over 87% data accuracy during quality control (QC) reviews. • Proactively identified and resolved case discrepancies, collaborating with team leads/SMEs and case processors to maintain workflow continuity.
Education
TULIP PUBLIC SCHOOL ETAH
10th
2015 — 2016
GLA University
Master's degree
2022 — 2024
TULIP PUBLIC SCHOOL ETAH
12th
2017 — 2018
GLA University
Bachelor of Pharmacy
2018 — 2022
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.