Pharmacovigilance Operations Specialist

A fast-growing Biotechnology company based in San Diego is in need of a Pharmacovigilance Operations Specialist for a part-time 6-month project (possible extension). This will be 20 hours/week. This consultant can work remotely but must be able to support West Coast hours as needed by the client, it is ideal if this consultant is based on the West Coast.
The client company is a smaller Biotech company that is a part of a larger pharmaceutical organization. The biotech company is using the large company's infrastructure for reporting, so they'd prefer to hire someone who has supported a similar dynamic before.Key Responsibilities:

• Serve as a key PV operations resource (non-medic role), focused on process oversight and optimization rather than case review.
• Able to support the full safety reporting lifecycle: from receipt of safety reports to querying, escalation, and submission to global regulatory authorities.
• Ensure processes are robust, efficient, and compliant.
• Ability to navigate a complex reporting system within a large pharma infrastructure; track individual case reports and ensure they move smoothly through the workflow.
• Follow up on reports requiring clarification or justification.
• Provide insights drawn from experience in both large pharma and smaller biotech environments.

Qualifications:

• 10+ years of pharmacovigilance experience, with a strong focus on PV operations.
• BS degree minimum
• Previous experience in both large pharmaceutical/biotech companies and smaller biotech organizations.
• Solid understanding of global safety reporting regulations and infrastructure navigation in small and large organizations.
• Strong communication, organizational, and follow-up skills.
• Proven ability to work independently while coordinating with stakeholders.
• Oncology therapeutic area experience is required.
• Ability to support West Coast working hours as needed.

Job Types: Part-time, Contract

Expected hours: 20 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Education:

• Bachelor's (Preferred)

Experience:

• pharmacovigilance: 10 years (Preferred)
• supporting large and small biotech/pharma companies: 8 years (Preferred)
• global safety reporting: 8 years (Preferred)
• infrastructure navigation: 8 years (Preferred)
• oncology: 8 years (Preferred)

Work Location: Remote