Manager, PVRM

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Deliver support for pharmacovigilance and risk management throughout the lifecycle of assigned products.

• Oversee the benefit-risk profile of products, ensuring patient safety and adherence to regulatory requirements.

• Engage in signal detection, aggregate safety reporting, safety governance forums, and preparation for inspections.

• Act as a subject matter expert within the designated program(s).

⛳️ Requirements

• A minimum of a bachelor’s degree in a healthcare or life sciences related field.

• A master's degree or other advanced education is preferred.

• At least 4 years of experience in pharmacovigilance within the pharmaceutical industry.

• Previous experience in oncology and/or neurology is highly preferred.

• A thorough understanding of FDA and EU legislation as well as GCP/GVP/ICH safety standards for investigational and marketed products.

🏝️ Benefits

• Merit-based salary increases.

• Participation in a short incentive plan.

• Eligibility for our 401(k) plan.

• Comprehensive medical, dental, vision, life, and disability insurance options.

• Flexible paid time off.

• 11 paid holidays, along with additional time off during the last week of December for a shutdown period.

• 80 hours of paid sick leave provided upon hire and each subsequent year.