Experienced Drug safety/Clinical safety professional

A Dentist by education and having worked within Pharmacovigilance industry for over 12 years, I have developed a wide range of skills within in the Pharmacovigilance industry.

• case processing
• clinical safety
• Drug Discovery
• drug safety
• eTMF
• Gute Klinische Praxis
• pharmacovigilance
• Safety management plan
• study protocol

Experienced professional with 12 and half years of experience in Pharmacovigilance Industry
Clinical Safety Manager at present, responsible for review of study protocols, Request for Proposal’s and Budget grid, electronic Case Report Forms,
Investigator sponsor studies agreement, eTMF, TOP etc, drafting of safety and risk language for Informed Consent Forms and Safety Management plans, performing SAE and ISS reconciliation and follow up Query management.
Worked on development, testing, validation and successful implementation of a BOT for an internal business process as a part of Robotic Process Automation.
Good knowledge on Safety databases
Worked on upgrade of safety database from business perspective for Query Management.
Sound knowledge on ICSR compliance management and CAPA handling.
Basic knowledge on Signal management and first hands on experience on Empirica.
Proven experience in customer handling and relationship and People management skills
Worked as Assistant Project Manager, managing project team for ICSR processing (Quality review team) and actively
involved in the development of Pharmacovigilance process management and review tools.
Excellent knowledge on case processing (clinical trial, post marketing, Literature and Business partner cases).
Worked on multiple therapeutic areas: Oncology,Neurology, Endocrinology and metabolic disorders, cardiovascular system, Infectious diseases and consumer health care.

Clinical Safety, Automation, Drug safety, Safety database, Compliance management