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

Workflow Manager Pharmacovigilance Operations (Specialist II PSS) US or Canada Remote

Fortrea is seeking a Workflow Manager Pharmacovigilance Operations (Specialist II PSS) is 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 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 Companys Health and Safety Manual.

Summary of 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 expediting 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.

Qualifications (Minimum Required):

• 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.

Experience (Minimum Required):

• Minimum of 2 years of pharmacovigilance (PV) work experience. Experience supporting U.S. and/or Canadian regulatory environments is preferred.
• Advanced command of English language including speaking writing and reading.
• Strong knowledge of safety databases (e.g. Argus)workflow tracking systems and case managementtools
• 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.

Preferred Experience:

• 4-5 years of experience in pharmacovigilance or drug safety operations
• Bachelors degree in life sciences pharmacy or a related field preferred; equivalent combination of education and relevant experience will also be
  considered.

***This is a INDIVIDUAL CONTRIBUTOR role.***

Work Environment:

• Work is performed in a remote based office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists
• Occasional crouching stooping with frequent bending and twisting of upper body and neck
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
• Regular and consistent attendance
• Varied hours may be required

Pay Range:

Benefits:All job offers will bebased on a candidates skills and prior relevant experience applicabledegrees/certificationsas well as internal equity and market data.

Application Deadline: August 9 2026

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