PV Operations Manager: Safety & Submissions Leader

Summit Therapeutics, Inc.; Menlo Park (CA); On-site; USD 122,000 - 143,000; Full time

Job summary

A biopharmaceutical company in Menlo Park seeks a Manager, Pharmacovigilance Operations to lead safety reporting and compliance. The successful candidate will have a Bachelor's degree in a health-related field and at least 5 years in pharmacovigilance within Biotech, Pharma, or a CRO. Responsibilities include developing safety procedures, overseeing ICSR submissions, and collaborating with various stakeholders to enhance safety management. Competitive compensation between $122,000 and $143,000 annually is offered, with potential bonuses and benefits.

Qualifications

• Minimum of 5 years of experience in pharmacovigilance in Biotech, Pharma or a CRO.
• Prior experience in Clinical Safety and Risk Management.
• Knowledge of ICH guidelines and global PV regulations.

Responsibilities

• Support development of PV documentation and SOPs.
• Oversee study management, submissions and safety document archival.
• Support audits and inspections.

Skills

Ability to translate PV knowledge and expertise into action

Effective collaboration and interpersonal skills

Experience working in a matrixed and fast-paced environment

Education

Bachelor’s degree in a health related field (RN, MSN, MPH, etc.)

Tools

Safety Database (Argus, ARISg, etc.)

Job description

A biopharmaceutical company in Menlo Park seeks a Manager, Pharmacovigilance Operations to lead safety reporting and compliance. The successful candidate will have a Bachelor's degree in a health-related field and at least 5 years in pharmacovigilance within Biotech, Pharma, or a CRO. Responsibilities include developing safety procedures, overseeing ICSR submissions, and collaborating with various stakeholders to enhance safety management. Competitive compensation between $122,000 and $143,000 annually is offered, with potential bonuses and benefits.