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.

Responsibilities

+ 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.

Essential Skills

+ 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.

Additional

Skills & Qualifications

+ Master's degree in a Science or Healthcare-related discipline, or equivalent experience.

Work Environment

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.

Job Type & Location

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

Pay and Benefits

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

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. 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
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Final date to receive applications

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

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a Clearly Rated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable…