Job Description

Lumicity is partnered with an exciting biotechnology research organization with locations across California who specialize in the development of drugs and treatments to revolutionize how we care for those hard-to-treat diseases/illnesses.

The team is looking to hire a Manger of Drug Safety & Pharmacovigilance and are open to both contract and permanent hire applicants.

Responsibilities:

• Oversee case processing, SAE reconciliation, and vendor communications to ensure timely and accurate safety data reporting.
• Develop and maintain safety management plans, PV agreements, and safety reporting systems.
• Manage vendor relationships, including KPIs, compliance, and process improvements.
• Support regulatory submissions for ICSRs, DSURs, and aggregate reports, ensuring alignment with global regulations.
• Conduct secondary quality reviews for safety cases and maintain data integrity in safety databases.
• Monitor adverse event trends, perform signal detection, and support safety surveillance activities.
• Collaborate cross-functionally to ensure compliance with clinical, regulatory, and quality standards.
• Contribute to inspection readiness, safety database updates, and quality management systems.
• Support safety document development, including protocols, IBs, and risk management plans.

Requirements:

• Bachelor’s degree in health-related field with 5+ years in drug safety/pharmacovigilance.
• Experience with safety databases (e.g., Argus), MedDRA/WHO coding, and safety operations.
• Proficient in regulatory compliance (e.g., ICH E2B) and aggregate report preparation.
• Strong organizational skills and ability to manage multiple projects effectively.

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