Senior Pharmacovigilance Scientist: ICSR & Safety Lead

247Hire; California (MO); On-site; USD 120,000 - 170,000; Full time

Job summary

Genentech is seeking a Pharmacovigilance professional to monitor drug safety, evaluate adverse events, and ensure data integrity in the global safety database. The role includes leading quality reviews of ICSRs, preparing executive summaries on quarterly trends, and driving continuous PV process improvements.

The position requires a Health Care Professional degree and strong writing skills in medical contexts; travel to domestic and international sites may be required to support audits and

Qualifications

• Requires ability to comprehend medical information and summarize complex data.
• Experience with pharmacovigilance processes and HA submissions preferred.

Responsibilities

• Complete drug safety monitoring and data entry of adverse events in global safety database.
• Lead quality reviews of ICSRs and ensure adherence to SOPs and regulatory standards.
• Develop executive summaries on quality trends quarterly.
• Train internal staff and vendors on PV processes and use of the safety database.
• Collaborate with departments to ensure timely data exchange and issue resolution.

Skills

Medical data comprehension

Ownership and accountability

Decision making

Leadership

Independent collaboration

Analytical evaluation

Communication & presentation

Agile adaptability

Attention to detail

Travel willingness

Writing and scientific writing

Education

Health Care Professional degree

Job description

Genentech is seeking a Pharmacovigilance professional to monitor drug safety, evaluate adverse events, and ensure data integrity in the global safety database. The role includes leading quality reviews of ICSRs, preparing executive summaries on quarterly trends, and driving continuous PV process improvements.

The position requires a Health Care Professional degree and strong writing skills in medical contexts; travel to domestic and international sites may be required to support audits and