Associate Director - Hawkins, United States - Infinity Technologies

Infinity Technologies

Verified Company

Hawkins, United States

1 week ago

Posted by:

Michael Johnson

beBee Recruiter

Description

THE COMPANY

We are currently seeking an Associate Director Patient Safety Physician (gn) for the Inflammation therapeutic area at a globally leading (bio)pharmaceutical company. In this role, you will be responsible for coordinating global initiatives for Patient Safety and Pharmacovigilance (PSPV) and Risk Management (RM) for compounds at various stages of development. You will work closely with the clinical development department in a strategic and global capacity.

YOUR RESPONSIBILITIES

Developing proactive and patient-centric RM strategies for designated compounds.
Overseeing and executing all PV activities for assigned drugs, including database setup, safety monitoring, and addressing safety concerns.
Collaborating with cross-functional teams, such as Clinical Development and Global Patient Engagement, to create patient-centric benefit-risk evaluations for developmental compounds.
Working with Global Epidemiology and Medical Affairs to design post-authorization studies focused on safety.
Analyzing safety data from clinical trials to incorporate into reports and regulatory submissions.
Providing medical-scientific insights for regulatory documents, including PSURs, DSURs, RMPs, and Clinical Overview Statements.
Keeping senior management informed of the safety profile of designated drugs and making recommendations for PV/RM actions.

YOUR PROFILE