Creative Operations Manager orchestrating resourcing and integrated delivery for GALE, a business agency. Managing creative capacity, staffing, production traffic, and client - facing project execution.
About the role
- Pharmacovigilance workflow manager overseeing adverse-event workflows, expedited reporting, and safety database reconciliation. Supporting Fortrea clinical-trial and post-marketing drug-safety operations.
Responsibilities
- Manage the receipt and processing of adverse event reports from spontaneous sources and clinical trials
- Enter safety data into the safety database and review adverse events
- Write patient narratives with coding
- Follow up on missing information
- Assess cases against the appropriate 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 when required
- Prioritize cases requiring expedited reporting and ensure submission within regulatory and study-specific timelines
- Work with Data Management or clients on reconciliation of safety databases, when appropriate
- Support audit or inspection preparations
- Coordinate workflow activities across safety operations
- Monitor case progression and compliance metrics
- Identify and resolve workflow delays
- Ensure efficient utilization of resources and high-quality service delivery
- Provide operational support to client project teams and standalone programs
- Comply with applicable pharmacovigilance regulations, company procedures, quality standards, and health and safety requirements
- Perform other 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 relevant experience
- Minimum of 2 years of pharmacovigilance (PV) work experience
- 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
- Candidates must be legally authorized to work in the country in which they reside (United States or Canada)
- Fortrea is unable to provide current or future employment sponsorship for this position
- Regular and consistent attendance
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
- Ability to perform the stated physical requirements, including occasional crouching, stooping, bending, twisting, and light to moderate lifting/carrying of 15-20 lbs
- Bachelor’s degree in life sciences, pharmacy, or a related field preferred; equivalent combination of education and relevant experience will also be considered
- Experience 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 domestic and international
- 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
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