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.