Safety Operations Submission Associate (6543)

Introduction & Summary:

The Safety Operations Submission Associate is crucial in ensuring the compliant and timely submission of Individual Case Safety Reports (ICSRs) to affiliates and health authorities globally. This role demands strong knowledge in pharmacovigilance and ICSR submission, requiring a methodical and detail-oriented approach to support global regulatory compliance and effective collaboration across international teams.

Main Responsibilities:
Key duties include:

• Manage the daily submission of Individual Case Safety Reports (ICSRs) to maintain regulatory compliance.

• Support database users with regulatory reporting requirements.

• Collaborate with international submission teams to address submission failures.

• Contribute to the development and enhancement of submission processes.

• Engage in knowledge sharing and training efforts to optimize team performance.

Key Requirements:

• Bachelor’s degree with familiarity in medicinal terminology.

• Experience in pharmacovigilance, particularly with ICSR submissions.

• Proficiency in IT databases and web solutions, preferably Argus or Veeva Safety.

• Detail-oriented and structured approach to tasks.

• Commitment to high-quality work and adherence to procedures.

• Service-oriented mindset and ability to manage priorities effectively.

• Fluency in English with skills to collaborate across cultures.

Nice to Have:
Complementary skills include:

• Experience processing cases or reports in Argus or Veeva Safety.

• Ability to learn quickly in a dynamic environment.

Other Details:
This role supports global regulatory compliance within Safety Operations, and offers opportunities to improve processes and engage in knowledge training within an international setting.