Disha Manhas

Pharmacovigilance professional with 4+ years of experience in end-to-end ICSR lifecycle management, regulatory reporting, and global safety compliance. Hands-on expertise in Argus case processing and validation testing, Health Authority case retrieval (EMA, TGA and other portals), and Pharmacovigilance Agreement (PVA) support. Experienced in MedDRA coding, regulatory intelligence monitoring, and mentoring junior associates.

Strong foundation in clinical research with a clear understanding of global safety regulations and compliance requirements.

Patient Safety Associate II - Parexel International Services India Private Limited - Mohali (Punjab), India

(2021-06)

• Manage end-to-end lifecycle of Individual Case Safety Reports (ICSRs) including triage, case processing, MedDRA coding, narrative writing, follow-ups, and submissions to regulatory authorities and partners.
• Retrieve and process Health Authority cases via EMA, MHRA and other regulatory portals, ensuring compliance with global reporting timelines.
• Perform duplicate detection, case validity assessment, and regulatory submission tracking.
• Conduct configuration testing in Development and Validation environments within Argus Safety database for new workflow changes.
• Support drafting and impact assessment of Pharmacovigilance Agreements (PVAs), including amendments and compliance tracking.
• Monitor regulatory intelligence updates through ISRR to ensure global compliance alignment.
• Generate safety listings and maintain audit-ready documentation.
• Mentor junior associates in EudraVigilance triage, mailbox management, and ICSR review processes.
• Manage translation records and ensure accurate reconciliation of ICSRs.
• Ensure strict adherence to data quality, confidentiality, and global regulatory standards.

Clinical Research Coordinator - Ethicscare Clinical Research Private Limited - Chandigarh, India

(2019-01 - 2021-02)

• Assisting the investigator in conducting the study as per SOPs, regulations and GCP guidelines.
• Reviewing patient data and identifying potential patients for the study.
• Helping the investigator in screening patients and ensuring compliance of project specific schedule of activities.
• Assisting the investigator in informed consent process, coordinating and managing laboratory samples and ensuring courier and follow up of lab reports.
• Maintaining drug accountability and dispensing at the site and ensure proper management, temperature monitoring.
• Verifying the accuracy and validity of data entered in databases, correcting any errors.
• Update case reports and source documents.
• Management of Site Master File.

Msc - Clinical Research - Rayat-Bahra University (2017 - 2019)

Bsc (Hons) - Zoology - Govt PG College (2014 - 2017)

10+2 - Govt Senior Secondary School, Gharjarot (2013 - 2014)

10th - Adarsh Bharti Public High School, Sugnara (Nagrota Surian) (2011 - 2012)