Workflow Manager, Pharmacovigilance Operations – Specialist II

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Oversee the receipt and processing of adverse event reports originating from spontaneous sources and clinical trials.

• Input safety data into the safety database and evaluate adverse events.

• Compose patient narratives along with coding.

• Follow up on any missing information.

• Evaluate cases against the relevant product label for marketed products, if applicable.

• Submit expedited Serious Adverse Event reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners, and Fortrea project personnel as needed.

• Prioritize cases that require expedited reporting and ensure submissions adhere to regulatory and study-specific timelines.

• Collaborate with Data Management or clients on the reconciliation of safety databases when appropriate.

• Assist in preparations for audits or inspections.

• Coordinate workflow activities across safety operations.

• Monitor the progression of cases and compliance metrics.

• Identify and address workflow delays.

• Ensure optimal resource utilization and deliver high-quality service.

• Provide operational support to client project teams and standalone programs.

• Adhere to applicable pharmacovigilance regulations, company procedures, quality standards, and health and safety requirements.

• Carry out additional duties as assigned by management.

⛳️ Requirements

• Non-degree + 2-3 years of Safety experience or 5 years of relevant experience.

• Associate degree + 2-3 years of Safety experience or 4 years of relevant experience.

• BS/BA + 2 years of safety experience or 3-4 years of relevant experience.

• MS/MA + 2 years of safety experience or 2-3 years of relevant experience.

• PharmD + 2 years of safety experience or 2-3 years of relevant experience.

• At least 2 years of pharmacovigilance (PV) work experience.

• Proficient command of the English language, including speaking, writing, and reading.

• Strong understanding of safety databases (e.g., Argus), workflow tracking systems, and case management tools.

• Excellent organizational and project management skills.

• Analytical mindset with strong problem-solving abilities.

• Good grasp of ICH guidelines and global regulatory requirements for reporting adverse events for both marketed and investigational products.

• Candidates must be legally authorized to work in the country where they reside (United States or Canada).

• Fortrea is unable to provide current or future employment sponsorship for this role.

• Consistent and regular attendance is required.

• Capability to access and utilize various computer software developed both in-house and commercially.

• Ability to meet physical requirements, including occasional crouching, stooping, bending, twisting, and light to moderate lifting/carrying of 15-20 lbs.

• A Bachelor’s degree in life sciences, pharmacy, or a related field is preferred; equivalent combinations of education and relevant experience will also be considered.

• Experience in supporting U.S. and/or Canadian regulatory environments is preferred.

• Preferred experience: 4-5 years in pharmacovigilance or drug safety operations.

🏝️ Benefits

• Remote-based office environment.

• Occasional travel both domestically and internationally.

• All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.