Manager, Post-Marketing Pharmacovigilance

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

📋 Description

• Assist in vendor management and oversee the complete ICSR collection, processing, reconciliation, and safety reporting tasks for post-marketing cases handled by the safety vendor.

• Evaluate safety vendor project plans to confirm that processes and procedures are accurately documented and kept up to date.

• Track safety vendor deliverables and action items to ensure adherence to established timelines.

• Offer guidance and subject matter expertise to the safety vendor regarding pharmacovigilance operational activities.

• Guarantee timely submission of expedited and aggregate safety reports through effective vendor oversight and regular assessment of vendor performance metrics.

• Conduct routine retrospective quality control assessments of safety cases managed by the safety vendor.

• Supervise reconciliation efforts between the safety database and Call Center as well as other post-marketing sources.

• Assist in the development and upkeep of internal pharmacovigilance policies, standard operating procedures (SOPs), and training programs.

• Contribute to the preparation and submission of safety reports, including PSUR/PBRER and PADER.

• Serve as the safety liaison between the pharmacovigilance department and internal stakeholders.

• Carry out additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree in life sciences (RN, Pharmacist) or equivalent experience.

• 4–6 years of direct experience in pharmacovigilance, focusing specifically on post-marketing safety.

• Profound understanding of FDA regulations.

• Experience with Argus is preferred.

• Exceptional written and verbal communication skills, capable of influencing and establishing credibility at all organizational levels.

• Strong interpersonal abilities for engaging with employees and leaders across various levels and departments.

• Detail-oriented with the capacity to manage multiple processes and documentation requirements.

• Strong technical and analytical capabilities, with advanced proficiency in MS Office applications including Word, Excel, and PowerPoint.

• Ability to work effectively in a team setting or independently as needed.

• Excellent organizational skills with the ability to prioritize effectively.

• Proven independent decision-making skills; capable of critical thinking and making decisions in a fast-paced environment.

• A mindset focused on continuous improvement, actively seeking methods to enhance innovation and efficiency within the organization.

• Adaptable and eager to learn; able to respond to business and site needs in a dynamic environment.

• Maintain a friendly, approachable, and professional demeanor.

🏝️ Benefits

• Annual performance incentive bonus.

• New hire equity package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) match.

• Paid time off (PTO).

• Paid holidays.