Job Description

Position : Safety Scientist

Location : Remote

Start Date : Mid May

Key Responsibilities :

• Review and assess safety data cases in the safety database to ensure compliance with regulatory requirements.
• Prepare and update periodic safety reports, including PBRERs, DSURs, and RMP updates.
• Update and maintain R&Ps (Regulatory & Procedural documents) in line with industry regulations and company policies.
• Represent the Safety Science Team in discussions regarding mature products and outsourced activities.
• Collaborate cross-functionally with regulatory, clinical, and medical affairs teams to ensure timely, accurate safety data management.
• Actively contribute to the successful transition of safety responsibilities as BioMarin moves towards outsourcing through a full-service provider.
• Troubleshoot and propose solutions to any challenges that arise with safety data management and reporting.

Qualifications:

• Advanced medical or scientific degree preferred (RN, MD, MBChB, PharmD, or Physician Assistant).
• At least 3 years of experience in pharmacovigilance, safety data review, or a related field.
• Familiarity with regulatory frameworks (e.g., FDA, EMA, ICH-GCP) and safety reporting requirements.
• Experience with safety database management systems (e.g., Argus, Veeva Vault QMS, or similar systems) is highly preferred.
• Strong communication and interpersonal skills to work effectively with cross-functional teams.
• Proven ability to manage multiple priorities and tasks in a fast-paced, evolving environment.

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