Heena Pancholi Sharma

Currently managing pharmacovigilance systems and ensuring compliance as the EU QPPV. Responsible for the build-up and maintenance of PV systems, medical due diligence, and consulting on PV topics.

Worked as a product manager for the development of PV databases using AI tools and automation, facilitating global client interactions and product delivery.

Served as a subject matter expert in pharmacovigilance operations, focusing on training, resource planning, and process improvements.

Conducted end-to-end ICSR case processing activities and trained client operations processing units in multiple global locations.

Assisted in regulatory affairs document submissions and set up a medical information call center team for multiple products.

Worked as a Pharmacovigilance Specialist, focusing on operations, training, and software compliance.

Served as a Pharmacovigilance Analyst, responsible for end-to-end ICSR case processing activities and training in MedDRA coding.

Worked as a Pharmacovigilance Scientist, assisting in regulatory document submissions and setting up a medical information call center team.

Qualified healthcare professional with 10 years of experience in Pharmacovigilance, drug safety, pharmaceutical drug lifecycle, and medical advisory services.