Job Description

Job Title: Pharmacovigilance Specialist

Location: Los Angeles, CA

Duration: 12 Months

Job Description:

We are seeking a dedicated and detail-oriented Pharmacovigilance Specialist to join our team for a 12-month contract position. In this role, you will provide operational support for global pharmacovigilance activities related to marketed products. You will be responsible for ensuring pharmacovigilance deliverables are of the highest quality, compliant with global regulatory reporting timelines, and effectively support our safety data review, compilation, and analysis.

Key Responsibilities:

Adverse Event Management:

• Process adverse event case reports and conduct follow-up as needed.
• Notify regulatory agencies and business partners, responding to requests from these agencies.

Literature Review & Reporting:

• Review scientific literature and bibliographic sources.
• Draft and manage Periodic Safety Update Reports (PSURs).

Safety Evaluation:

• Evaluate safety profiles and manage signal detection reports.
• Ensure proper document filing and archiving in compliance with standards.

Pharmacovigilance Processes:

• Participate in the collection, processing, review, and distribution of adverse event information for both development and marketed products.
• Ensure compliance with pharmacovigilance activities, including case reconciliation with affiliates, distributors, and business partners

Compliance & Audits:

• Contribute to self-inspection visits, audits, and inspections.
• Assist in CAPA (Corrective and Preventive Action) management.
• Create and update pharmacovigilance procedures and working practices.

Training & Documentation:

• Provide training on pharmacovigilance processes based on the training plan.
• Manage training documentation and archive documents according to regulatory standards.

Global Operations Support:

• Support in the creation and implementation of global pharmacovigilance operations, including Standard Operating Procedures (SOPs), internal business practices, and working instructions.

Advisory Role:

• Serve as an advisor on product monograph reviews.
• Draft responses to pharmacovigilance-related requests from regulatory agencies.
• Participate in the drafting and implementation of pharmacovigilance contracts and agreements.

Qualifications:

• Bachelor's degree in life sciences or related field (Pharmacy, Biology, Medicine, etc.).
• Previous experience in pharmacovigilance or related fields is preferred.
• In-depth understanding of regulatory requirements related to pharmacovigilance activities.
• Strong analytical skills and experience managing safety data.
• Excellent communication and organizational skills.
• Ability to work collaboratively in a fast-paced, global environment.

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