Pharmacovigilance

Seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function for Dr. Reddys North America Generics and affiliates as well as Dr. Reddys Canada

Develop and execute quality and compliance monitoring activities for PS processes within area of expertise to support a robust GVP Quality Management System.

Coordinate with cross-functional teams to ensure seamless integration of safety data into the overall drug development process. Monitor and evaluate adverse event reports to identify potential safety signals and trends.

May enter data or assist in the creation of cases into the safety database in accordance with Sponsor, customer specific guidelines and Company standards if required.

In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. Your expected interactions are within your own team and direct supervisor.

Masters in Pharmacy / Doctor of Pharmacy - Good knowledge of computers is desirable. 0–1 year experience in Pharmacovigilance / Surveillance / Medical Devices / Quality Assurance / Regulatory Affairs or Quality Management System

Master degree in Pharmacy, Clinical Pharmacology, Pharmacy Practice and Clinical Research OR Pharm.D, MBBS, BDS from a recognized university, institute.

Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures. 

As a Senior Auditor Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of in Native treatments and therapies.