Associate Director - East Springfield, United States - Sapphire Enterprises

Sapphire Enterprises

Verified Company

East Springfield, United States

3 weeks ago

Posted by:

Meredith Sinclair

beBee Recruiter

Description

THE COMPANY

We are currently seeking an Associate Director Patient Safety Physician (gn) for the Oncology department of a leading (bio)pharmaceutical company in East Springfield. In this role, you will be responsible for overseeing 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.
Managing all PV activities for assigned drugs, including database setup, safety monitoring, and addressing safety concerns.
Collaborating with cross-functional teams to evaluate the benefit-risk profile of developmental compounds.
Working with Global Epidemiology and Medical Affairs to design post-authorization safety studies.
Analyzing clinical trial safety data for use in reports and regulatory submissions.
Providing medical-scientific insights for regulatory documents such as 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