Senior Manager, Pharmacovigilance

Job Description

Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products
Contribute to safety sections of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and IND/NDA/MAA/CTAs (as applicable)
Support preparation and submission of DSURs, periodic safety reports/listings, and updates to Investigator Brochures (IBs)
Develop, maintain and execute Safety Management Plans for clinical studies
Support launch readiness activities including development of post-marketing pharmacovigilance processes, development and maintenance of Risk Management Plans (RMPs) and REMS (as applicable)
Assist with preparation for regulatory inspections and audits

Qualifications

• Bachelor’s degree in life sciences, pharmacy, nursing, or related discipline with demonstrated knowledge of medical terminology
• 12 years’ pharmacovigilance experience with Bachelor's degree -or- 8 years’ experience and Master's degree -or- 5 years’ experience and PhD-including clinical trial and/or post-marketing experience
• Experience with small-molecule oncology products
• Working knowledge of global pharmacovigilance regulations, including FDA, EMA, Health Canada, and Asian Health Authorities (e.g., Japan PMDA, South Korea MFDS)
• Experience using validated safety databases (e.g., Argus, ARISg) and clinical trial databases

Preferred Qualifications

• Oncology experience in lung and/or prostate cancer
• Experience in biotech/ small pharmaceutical company or CRO environments
• Experience supporting NDA/MAA submissions and commercial launch
• Familiarity with REMS, RMPs, and post-marketing commitments

Skills and Attributes

• Strong strategic thinking combined with a hands-on, execution-focused mindset
• Proven ability to collaborate and lead in a cross-functional, matrixed organization
• Excellent written and verbal communication skills, with the ability to convey complex data clearly
• Highly organized, adaptable, and comfortable working in a fast-paced, evolving environment
• Mission-driven, patient-focused, and committed to scientific integrity

Additional Information

The anticipated salary range for candidates who will work on-site at our San Diego location is between $150,000-$180,000. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.