Priyanka D.

About Priyanka D.

Detail-oriented Safety Science Analyst with hands-on experience in Pharmacovigilance and ICSR case processing, including spontaneous report cases.*Proficient in Argus Safety database handling for end-to-end case processing, data entry, MedDRA coding, medical assessment, seriousness assessment and high-quality narrative writing in compliance with global regulatory guidelines.*Actively involved in data entry and also done quality review of cases, consistently maintaining high accuracy, strong compliance, and excellent productivity while meeting strict regulatory timelines.*Holds an M. Pharmacy in Pharmacology with a strong academic foundation in pharmacology, drug safety, and adverse event evaluation.*Motivated to contribute to patient safety and grow within global drug safety and pharmacovigilance roles.

Experience

1. Safety Science Analyst

   Fortrea

   Jul 2025 — Present · Pune, IN

   Perform data entry and quality reviews of incoming safety information or reports from spontaneous reports.•Assist with processing of the adverse events, including but not limited to: Data entry of safety data onto adverse event tracking systems. Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable). Assist in the listedness assessment against appropriate label (for Marketed products, if applicable). Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed. Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines.•Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel etc.), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines.•Assist in the reconciliation of databases, as applicable. Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate•Assist in the maintenance of supporting files/documentation regarding adverse event reporting requirements in all countries, if applicable•Support upload/archival of case/study/project documentation, as appropriate•Build and maintain good PSS relationships across functional units•Support compliance of operations with governing regulatory requirements•All other duties as needed or assigned

Education

• Savitribai Phule Pune University

  Master's degree, Pharmacology and Toxicology

• CLINI INDIA

  Advance Program in Clinical Research and Management

• Shri Chhatrapati Shivaji Mahavidyala Shrigonda

  Higher Secondary Certification , Science

• Dr. Babasaheb Ambedkar Technological University

  Bachelor of Pharmacy - BPharm, Pharmacy

• Shri Vyankanath Vidyalaya Loni Vyankanath

  Senior Secondary Certification