Job Overview:

The Team Manager of PSS will lead or assist with the management of PSS concerning project allocation and resourcing. This will include general oversight for the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial.

Summary of Responsibilities:

• Responsible for the line-management of individuals within team and a project team.
• Manage direct reports to ensure staff training records are up to date.
• Responsible for managing performance reviews and issues of direct reports.
• May manage individuals across multiple teams and will take on responsibility for cross department projects.
• Responsibilities will include, but are not limited to, oversight of the following types of tasks:
• Entry of safety data onto adverse event tracking systems.
• Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting.
• Write patient narratives.
• Code adverse events accurately using MedDRA.
• Clinically significant information missing from initial reports and ensures its collection.
• Ensure cases receive appropriate medical review.
• Prepare follow-up correspondence consulting with the medical staff accordingly.
• Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines.
• Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators, and project personnel, if required, within study specified timelines.
• General oversight for the management and processing of expedited safety reports (ESRs). This includes, but is not limited to, oversight of the following types of tasks:
• Review and update adverse event databases and tracking systems.
• Review of adverse events for completeness, accuracy, and appropriateness for ESR.
• Review of patient narratives.
• Review the coding of adverse events.
• Review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committees, investigators, and project personnel, if required, within study specified timelines.
• Complete triage, distribution checklist and quality review of all ESR for assigned projects.
• Execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.
• Maintain awareness of safety database conventions and system functionality.
• Maintain awareness of other client safety database conventions and functionality.
• Prepare and provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting.
• Responsible for the timely preparation and review of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
• Provide oversight and management of EudraVigilance activities for assigned projects.
• Provide oversight and/or perform signal detection and trend and pattern recognition activities, as required for assigned projects.
• Contribute to the generation and review of Time and Cost Estimates for PSS business.
• Line manage PSS staff including performance reviews, human resource issues, and assist Senior PSS Management in assigning resources to projects. The post holder is typically, but not exclusively, responsible for providing line management of junior PSS staff.
• Manage, coordinate, and oversee the overall PSS operations associated with the processes for adverse events and expedited safety reports to the required standard and ensure submission of them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for supporting team members in providing this service to clients either as a support function to the client project groups or as stand-alone business.
• Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.
• And all other duties as needed or assigned.

Qualifications (Minimum Required):

• At least 2 years in line management and/or project management experience.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Industry experience of which 4 years is relevant to pharmacovigilance/drug safety knowledge.
• Good verbal, written, and presentation skills.
• Ability to interact and influence with line and middle management, staff, and external contacts on a functional and tactical level.
• Strong leadership capabilities.

Experience (Minimum Required):

• High degree of accuracy with attention to detail.
• Knowledge of medical and drug terminology.
• Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
• Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products.
• Knowledge of Medical Device Reporting desirable.
• Knowledge of aggregate reporting desirable.
• Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
• Financially intuitive.
• Knowledge of ICH guidelines.

Preferred Qualifications Include:

• Non-degree plus 6-7 years safety experience* including 2 years of team leadership experience.
• ***Associate degree plus 5-6 years safety experience* including 2 years of team leadership experience.
• Associate degree plus 5-6 years safety experience* including 2 years of team leadership experience.
• BS/BA plus 4-5 years relevant experience* including 1-2 years of team leadership experience.
• MS/MA + 3-4 years relevant experience** (1-3 years safety experience) including 1-2 years of team leadership experience.
• ***PhD / PharmD + 2-3 years relevant experience** (1-2 years safety experience) including 0-2 years of team leadership experience.
• For PharmD, a one-year residency of fellowship can be considered relevant experience.
• Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area.
• *Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
• **Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
• ***Team leadership experience includes experience bearing overall responsibility for work products generated for customers by supporting team members operating in matrix environment, assigning, and coordinating work executed by a team of supporting staff, organizing efforts of more than one individual to achieve common team objectives.

Physical Demands/Work Environment:

• Available for travel 10-15% of the time including overnight stays as necessary consistent with project needs and office location.

Learn more about our EEO & Accommodations request here.