Pharmacovigiliance Portfolio Manager

Job Title:

Pharmacovigilance Portfolio Manager Job Description

The role involves overseeing Pharmacovigilance (PhV) portfolio management activities throughout the product lifecycle, excluding case management. The position supports the setup, maintenance, and closeout activities for various programs, providing global oversight for pipeline trials, post-marketing programs, and reporting requirements. It also involves standardizing collaboration across Development Operations, Data Management, Regulatory Affairs, Medical Affairs, and other relevant departments.

• Lead PhV project start-up, maintenance, and closeout activities, including Safety Reporting Plan review, safety database configuration/updates, and regulatory/submission impact analysis.

• Serve as the global PhV point of contact for key cross-functional departments including Development Operations, Medical Affairs, Data Management, Regulatory Affairs, and Commercial.

• Provide portfolio oversight support during audits and inspections, including CAPA/audit or inspection finding investigations and compilation of quality/compliance data.

• Coordinate GPRM efforts for new NDA/MAA regulatory tasks as required.

• Organize GPRM cross-department training and brainstorming sessions for new programs and/or products.

• Act as a Subject Matter Expert (SME) with business partners, PhV service providers, and CROs.

• Support Pharmacovigilance reconciliation of databases and listings for post‑marketing and clinical trial sources, as required.

• Assist with the creation of SOPs, working instructions, job aids, forms, and templates to support efficient project management processes.

• Ensure compliance with internal procedures, regulatory requirements, and business partner agreements to support inspection readiness.

• Minimum of 6 years of Pharmacovigilance experience or equivalent clinical/pharmaceutical experience.

• Minimum of 2 years of Project Management experience or equivalent relevant experience.

• Proficiency using safety database systems;
  Argus experience preferred.

• Advanced knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines, and Good Clinical Practices.

• Strong Microsoft Office skills, including Word, Excel, Outlook, and PowerPoint.

• Excellent organizational, time management, problem-solving, presentation, verbal, and written communication skills.

• Ability to work effectively in a team environment with fluency in written and verbal English.

• Master’s degree in a Science or Healthcare-related discipline, or equivalent experience.

This is a remote role with a preference for candidates in the Eastern Standard Time (EST) zone, though Central Standard Time (CST) is also acceptable. The position offers an opportunity to support a global Pharmacovigilance portfolio in an FSP model with exposure to cross-functional drug safety, regulatory, quality, and clinical operations stakeholders. It provides continued development in PhV portfolio oversight, inspection readiness, cross-functional project management, and global program support.

This is a Contract position based out of Wilmington, DE.

The pay range for this position is $65.00 - $67.00/hr.

If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits>>li>
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully remote position.

This position is anticipated to close on Aug 10, 2026.

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