Saryu Bakshi

Detail-oriented and highly motivated Bachelor of Dental Surgery (BDS) graduate with specialized training in Pharmacovigilance. Possesses strong clinical knowledge and hands-on experience in Individual Case Safety Report (ICSR) processing, Oracle Argus Safety Database, MedDRA coding, and medical narrative writing. Well-versed in global pharmacovigilance regulations including ICH-GVP, CIOMS, FDA, and EU guidelines.

Seeking an opportunity within the pharmaceutical and life sciences industry to contribute to patient safety, drug surveillance, and regulatory compliance.

Pharmacovigilance & Drug Safety - Parexel International Pvt Ltd

(2023-08 - 2025-12)

Experienced in management of Individual Case Safety Reports (ICSRs) (spontaneous, solicited, legal and pregnancy cases).

• Data entry of ICSRs, including expectedness determination, case summaries, and causality assessment.
• Data validation against source documentation.
• Experienced in MedDRA coding per "MedDRA Term Selection: Points to consider."
• Maintains strong knowledge of AE safety profiles, reference safety information, and global regulations (ICH, GVP, FDA, CIOMS, EU PV, GDPR).
• Manages workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
• Interacts with clients to resolve ICSR processing issues.
• Signal Detection & Risk Management.

Dental Practitioner - Himachal Dental College & Hospital

(2022-01 - 2023-01)

Responsibilities & Achievements

• Conducted patient examinations and diagnosed a wide range of dental and oral health conditions.
• Developed evidence-based treatment plans for patients.
• Performed restorative, periodontal, and minor oral surgical procedures under standard clinical protocols.
• Reviewed patient medical histories and medication records to ensure safe treatment delivery.
• Educated patients on preventive oral healthcare and hygiene practices.
• Maintained accurate clinical records and treatment documentation.

Bachelor of Dental Surgery - BDS - Himachal Dental College, Sundernagar, Himachal Pradesh (2017 - 2022)

Class XII - CBSE - Sri Guru Harkrishan Model School, Chandigarh (2016 - 2016)

Class X - ICSE - Mount Carmel Senior Secondary School, Palampur, Himachal Pradesh (2014 - 2014)