Ambika Tiwari

Pharmacovigilance Specialist with over 3 years of hands-on drug safety experience across pharmaceutical and CRO across the UK, underpinned by a medical degree (BHMS) covering anatomy, physiology, pathology, gynaecology & obstetrics and general medicine. Skilled in end-to-end Individual Case Safety Report (ICSR) processing, MedDRA coding, medical narrative writing, and E2B regulatory submissions to health authorities. Proficient with global safety databases (Argus, ARISg, Q-Pulse) and experienced in case triage, reconciliation, and quality review.

Strong working ability to apply clinical/medical knowledge alongside regulatory expertise to collaborate across clinical, medical and regulatory teams. MBA in healthcare (Brunel university UK)

Pharmacovigilance Specialist - MSD Pharmaceuticals UK - UK

(2021-12 - 2022-06)

• Performed complete end-to-end case processing, including receipt of SAE forms, case analysis and causality assessment
• Authored medical narratives and applied MedDRA coding to ensure accurate, compliant case documentation
• Transmitted cases from local to central safety database and managed daily case lists for submission to health authorities
• Maintained internal trackers and presented case-flow status; supported the medical information team

Drug Safety Associate - Lloyds Pharmacy, UK - UK

(2021-06 - 2021-08)

• Conducted case management and triage and authored medical narratives
• Completed data entry in the safety database (Q-Pulse) and performed daily audits and SQL checks

Drug Safety Associate - I-Pharma Support, UK - UK

(2020-05 - 2021-01)

• Triaged cases by seriousness criteria and handled case intake, duplicate checks and registration
• Wrote medically relevant safety narratives and verified completeness and accuracy of entered data
• Managed case allocation, workflow tracking and reconciliation to meet regulatory and internal timelines

Pharmacovigilance Intern - GSK, UK - UK

(2019-10 - 2020-04)

• Supported pharmacovigilance activities, patient safety, complaints and governance workstreams
• Monitored local health authority updates and supported the team during audits

MBA - Healthcare Management - Brunel University London (2018-09 - 2019-09)

Bachelor of Homoeopathic Medicine & Surgery - BHMS - Devi Ahilya Vishwavidyalaya, India (2003 - 2009)

Diet & Nutrition Advisor - Nutrition Sciences - Stonebridge Associated Colleges, UK