Tejasree Edunoori

BDS graduate with 1.6 years of experience in Medical Affairs and Pharmacovigilance. Experienced in Reviewing of Individual Case Safety Report (ICSR) processing, aggregate safety reporting, medical review, adverse event assessment, regulatory compliance, documentation, and cross-functional collaboration. Detail-oriented professional committed to patient safety and high-quality pharmacovigilance practices, with a strong foundation in clinical and medical terminology drawn from a dental sciences background.

Drug Safety Physician — Medical Affairs & Pharmacovigilance - Mitocon Biopharma

• Reviewed and processed Individual Case Safety Reports (ICSRs), ensuring completeness, medical accuracy, and adherence to reporting timelines.
• Performed medical review and clinical assessment of adverse event cases, evaluating causality, seriousness, and expectedness.
• Contributed to the preparation and quality review of Aggregate Safety Reports in line with regulatory guidelines.
• Maintained strict compliance with Good Pharmacovigilance Practice (GVP), internal SOPs, and applicable regulatory requirements.
• Supported regulatory submissions through accurate, well-organized case documentation and audit-ready record keeping.
• Collaborated closely with medical, quality, and cross-functional teams to resolve case queries and ensure data consistency.
• Ensured timely and accurate processing of safety cases, consistently meeting internal and client turnaround-time targets.

BDS - Malla Reddy Dental College for Women (2020-01 - 2025-12)

Intermediate - Sri Chaitanya Junior College (2016-01 - 2018-12)

CBSE (Class X) - St. Peters Edu School (2015-01 - 2016-12)