Senior Medical Review Lead & ICSR Oversight (Remote)

Kinsley Power Systems; Cambridge (MA); Hybrid; USD 185.369 - 308.948; Vollzeit

Benefits dieser Stelle

Professional development opportunities

Flexible work arrangements

Premium benefits package

Performance-based compensation

Zusammenfassung

Agios Pharmaceuticals is seeking an Associate Director, Medical Review Lead to join the team in Cambridge, MA. This role involves oversight of medical review for Individual Case Safety Reports (ICSRs) to ensure compliance and quality of safety data. The successful candidate will have substantial experience in drug safety and vendor oversight.

We offer competitive compensation, flexible work arrangements, and comprehensive benefits. Commit to fostering a diverse and inclusive workplace while making a significant impact in rare disease communities.

Qualifikationen

• Minimum of 3 years of relevant drug safety/pharmacovigilance experience.
• 1-2 years of vendor oversight in the biotechnology/pharmaceutical industry is required.
• Ability to prioritize and multi-task effectively.

Aufgaben

• Provide oversight of medical review for Individual Case Safety Reports (ICSRs).
• Ensure compliance with regulatory and company standards during ICSR review.
• Partner cross-functionally for safety surveillance and risk management.

Kenntnisse

Drug safety/pharmacovigilance experience

Vendor oversight

MedDRA coding expertise

Software-based drug safety systems (e.g., ARGUS)

Expedited safety reporting knowledge

ICH regulations understanding

Strong communication skills

Strong computer skills (MS Office)

Ausbildung

MD/DO

Tools

ARGUS

ARISg

Jobbeschreibung

Agios Pharmaceuticals is seeking an Associate Director, Medical Review Lead to join the team in Cambridge, MA. This role involves oversight of medical review for Individual Case Safety Reports (ICSRs) to ensure compliance and quality of safety data. The successful candidate will have substantial experience in drug safety and vendor oversight.

We offer competitive compensation, flexible work arrangements, and comprehensive benefits. Commit to fostering a diverse and inclusive workplace while making a significant impact in rare disease communities.