Senior Manager, Pharmacovigilance (Contractor)

Position

We are seeking an experienced Senior Manager, Pharmacovigilance (Contractor) to join our team. The Senior Manager, Pharmacovigilance (Contractor) will be responsible for the management of safety data across our portfolio of products. The successful candidate will play a critical role in ensuring the safety of our patients by proactively monitoring and assessing adverse events, as well as working cross-functionally to ensure compliance with regulatory requirements. 

About You

You are a Pharmacovigilance expert with a passion for drug discovery. You are an analytical, detail-oriented, and you have an appreciation for compliance. You’re collaborative by nature with uncompromising integrity. You’re conscientious and pay almost obsessive attention to detail, documentation and organization are second nature. You are a self-starter in spirit. 

What You’ll Do

• Lead and manage pharmacovigilance activities for our clinical-stage programs.
• Collaborate cross-functionally with clinical development, regulatory affairs, medical affairs, and other teams to ensure the safety of our products.
• Oversee the development and maintenance of pharmacovigilance processes and procedures.
• ICSR Management: Safety mailbox management, safety data collection, end-to-end case processing (book in, triage, data entry, query generation, quality review, evaluation, medical review including narrative writing) and reporting in compliance with applicable regional regulations and guidelines.
• Generation and distribution of (periodic) line listings to business partners.
• Contribute as needed to the preparation and review of safety sections of regulatory submissions.
• Coordinate and manage relationships with external vendors and partners involved in pharmacovigilance activities.
• Provide pharmacovigilance expertise and support for product development and lifecycle management activities.

Qualifications:

• MD with 4+ years of experience in pharmacovigilance or drug safety, with a strong understanding of pharmacovigilance regulations processes. 
• Strong understanding of global regulatory requirement related to pharmacovigilance and guidelines (FDA, EMA, ICH, etc.).
• Proven technical aptitude with MS Office and Oracle ARGUS Safety Database is required.
• Proven ability to lead and manage pharmacovigilance activities independently.
• Excellent communication skills and ability to collaborate effectively across multidisciplinary teams.
• Detail-oriented with strong analytical and problem-solving skills.
• Experience with safety databases and pharmacovigilance systems.
• Experience in oncology or rare diseases is a plus.
• Previous experience interacting with health authorities during inspections and audits.

The expected hourly range for this role is $79/hour to $87/hour depending on skills, competency, and the market demand for your expertise. This is a contract role, expected to last approximately 3 months, with an anticipated workload of 40 hours per week.