Workflow Manager, Pharmacovigilance Operations (Specialist II, PSS) US Remote

Fortrea•Durham, CA

3d•$80,000 - $105,000•Remote

About The Position

Fortrea is seeking a Workflow Manager, Pharmacovigilance Operations (Specialist II, PSS) responsible for supporting and overseeing Clinical Safety and Pharmacovigilance Services (PSS) operations associated with safety data collected from clinical trials and post-marketing programs. The role is accountable for managing end-to-end safety case workflows, ensuring adverse events are processed, tracked, and progressed through all workflow stages in accordance with client requirements, regulatory obligations, and agreed timelines. The position is responsible for coordinating workflow activities across safety operations, monitoring case progression and compliance metrics, identifying and resolving workflow delays, and ensuring efficient utilization of resources to support high-quality service delivery. The Workflow Manager provides operational support to client project teams and standalone programs while maintaining compliance with applicable pharmacovigilance regulations, company procedures, and quality standards. The incumbent is expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH Regulations 1989, and the EC (European Commission) Directives 1992/3, as documented in the Company's Health and Safety Manual.

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 relevant experience
For PharmD, a one-year residency of fellowship can be considered as relevant experience
Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
Minimum of 2 years of pharmacovigilance (PV) work experience in US/Canada.
Advanced command of English language, including speaking, writing, and reading.
Strong knowledge of safety databases (e.g., Argus), workflow tracking systems, and case management tools
Strong organizational and project management skills
Analytical mindset with problem-solving capabilities
Good understanding of ICH guidelines and global regulatory requirements for the reporting of adverse events for both marketed and investigational products.

Nice To Haves

4-5 years of experience in pharmacovigilance or drug safety operations
Bachelor’s degree in life sciences, pharmacy, or a related field preferred; equivalent combination of education and relevant experience will also be considered.
Candidates must be authorized to work in the United States without the need for current or future visa sponsorship.

Responsibilities

Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited from a clinical trial including safety database entry, AE review, write patient narratives with coding, follow-up of missing information, lists assessment against appropriate label (For Marketed products, if applicable).
Submission of expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners and Fortrea project personnel, if required & as agreed with client during study set-up, within study specified timelines.
Ensure all cases that require expedited reporting to worldwide Regulatory Agencies or other recipients are prioritized for processing and submission within the regulatory and/or study specific applicable timelines.
Work with Data Management or client on reconciliation of safety databases, if appropriate.
Support audit or inspection preparations.
Any other duties as assigned by management.