Drug Safety Case Manager

Scorpion Therapeutics; California (MO); On-site; USD 95,000 - 135,000; Full time

Job summary

Scorpion Therapeutics seeks a Drug Safety Case Manager to support Cytokinetics' pharmacovigilance operations within cardiovascular therapeutics.

Responsibilities include processing safety reports under ICH-GCP, overseeing CRO activities for SAE processing, maintaining safety databases, and preparing regulatory safety reports, with strong cross-functional collaboration in a dynamic environment in South San Francisco, CA.

Qualifications

• 3–5 years of drug safety experience covering ICSR and periodic reporting.
• Familiarity with domestic and international PV regulations.
• Experience with Argus or ARISg databases.
• Strong MedDRA and WHODRUG coding skills.
• Proficient in MS Office.
• Excellent communication and organizational skills.
• Ability to work independently in a dynamic environment.

Responsibilities

• Process safety reports in accordance with ICH-GCP and regulatory standards.
• Oversee CRO activities related to SAE processing.
• Maintain safety databases.
• Prepare safety reports for regulatory submissions.
• Ensure departmental compliance with PV standards and regulations.
• Support study start-up activities as needed.
• Foster cross-functional collaboration across teams.
• Drive process improvement initiatives in pharmacovigilance.
• Deliver training on PV processes and regulatory requirements.
• Ensure regulatory adherence in all safety activities.

Skills

Drug safety experience

MedDRA coding

WHODRUG coding

Communication

Independence

Education

Life sciences degree

Tools

Argus or ARISg

MS Office

Job description

Role: Drug Safety Case Manager supporting Cytokinetics' pharmacovigilance operations within a specialty cardiovascular biopharma.

Responsibilities

• processing safety reports in compliance with ICH-GCP and regulatory standards
• overseeing CRO activities related to SAE processing
• maintaining safety databases
• preparing safety reports
• ensuring departmental compliance
• study start-up activities
• cross-functional collaboration
• process improvement
• training
• regulatory adherence

Qualifications

• Degree in life sciences
• 3-5 years' drug safety experience covering ICSR and periodic reporting
• familiarity with domestic and international PV regulations
• experience with Argus or ARISg databases
• strong MedDRA and WHODRUG coding skills
• proficient in MS Office
• excellent communication and organizational skills
• ability to work independently in a dynamic environment

Preferred: healthcare professional background (pharmacy, nursing).

High-Value: focus on pharmacovigilance for cardiovascular therapeutics, with emphasis on safety data analysis, regulatory reporting, and cross-departmental collaboration.

Work setup: location in South San Francisco, CA, with a competitive salary range, comprehensive benefits, and a focus on integrity and patient-centered actions.