Drug Safety Specialist

Job Summary:

The Clinical Medical Services Specialist III provides medical and pharmacovigilance support focused on the intake, assessment, and processing of adverse event information. This role oversees external vendors to ensure compliance with global regulatory requirements, supports case quality initiatives, and collaborates with cross-functional teams to maintain high standards of patient safety, quality, and regulatory compliance.

Key Responsibilities:

• Oversee external vendors to ensure timely and compliant collection, assessment, and processing of post-marketing adverse event reports.

• Review and support adverse event evaluations including seriousness assessment, causality, labeling, and follow-up activities.

• Monitor vendor performance to ensure quality, compliance, productivity, and adherence to established standards.

• Support case quality initiatives, processing metrics, and conti...