Subhasini Saravanan

About Subhasini Saravanan

Hi, Welcome to my page!I’m a passionate and detail-oriented pharmacovigilance specialist with more than 3 years of hands-on experience across the drug safety lifecycle. My expertise spans individual case safety report (ICSR) processing, global literature surveillance, and aggregate reporting, including contributions to DSURs and PBRERs across multiple projects.I have led literature workflows, ensured timely data submissions, and contributed to global safety compliance with regulatory standards. I’m also experienced in tools like Argus, Veeva Vault, and databases like PubMed and Embase.What sets me apart - I blend deep domain knowledge with team ownership, quick learning, and a proactive approach to cross-functional collaboration.If you’re looking for a reliable and driven PV professional who can hit the ground running, I’d be happy to connect.

Experience

1. Pharmacovigilance Associate

   ICON plc

   Jan 2023 — Present · Chennai, IN

   Conducted comprehensive literature reviews to identify and evaluate adverse drug reactions (ADRs) and safety signals from scientific publications, clinical studies, and case reports.•Performed literature search in publicly available databases (PubMed)/ local journals and triaged literature for Individual Case Safety Reports (ICSRs), PBRERs, and signal detection. •Contributed to the preparation and submission of periodic safety update reports (PSURs) and risk management plans (RMPs).•Collaborated with cross-functional teams to assess the benefit-risk profile of marketed drugs and support safety evaluations.•Performed signal detection activities using available data sources to identify potential safety concerns and escalate them appropriately.•Assisted in the preparation of safety-related communications, including risk communication to healthcare providers and regulatory authorities.•Managed and updated safety databases, ensuring accurate documentation of adverse event reports and literature findings.•Supported regulatory filings and submissions related to drug safety, including INDs, NDAs, and annual reports.•Ensured compliance with global pharmacovigilance regulations and guidelines (FDA, EMA, ICH E2E).•Participated in internal and external audits to assess adherence to safety protocols and improve pharmacovigilance processes.

Education

• SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES, COLLEGE OF PHARMACY

  Doctor of Pharmacy - PharmD, Pharmacy

  2016 — 2022

• Premier Vidyaa Vikash Matriculation Higher Secondary School

  Higher secondary

  2014 — 2016

• Avila Convent Matriculation Higher Secondary School

  Kindergarten - High school

  2000 — 2014