Associate Director PSS

Job Overview:

Responsible for managing the Patient Safety Solutions (PSS) regional operations group (Europe, Asia-Pacific or The Americas). Responsible for ensuring all domestic projects are allocated and set up in accordance with capabilities and current/expected workload, that assigned staff are adequately trained and developed, and that all projects remain on time and within budget. Responsible for ensuring the processing of expeditable adverse events meets the required standard; and submitting these events to the clients and regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for overseeing the provision of this service to clients either as a support function to the client project groups, or as a stand-alone business. It is the responsibility of the post holder to ensure that staff in own downline provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. They will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and EC (European Commission) Directives 1992/3 as documented in the Company's Health and Safety Manual.

Summary of Responsibilities:

• May manage from 1-5 direct reports and up to 50 indirect subordinates.
• Managerial and Leadership duties and responsibilities:
• Responsible for cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.
• May manage individuals across multiple teams Participate in Fortrea project teams and provide training about adverse event reporting to non-safety personnel.
• Train new employees overall in pharmacovigilance and regulatory reporting.
• Assist with the recruitment of new staff to Patient Safety Solutions.
• Ensure the set up and maintenance of project files and core process files.
• Contribute to the generation and review of Time and Cost Estimates for PSS business.
• Review safety costs for allocated projects, identify out-of-scope/unauthorized activities and work with the appropriate business units to process change orders, expeditiously.
• Review billed time to allocated projects for direct reports.
• Engage in skill assessment and active skill development of direct reports - implementing development plans to ensure talent development.
• Provide appropriate and relevant PSS input into project management, including risk analysis, control metrics and contingency planning.
• Liaise with medical, clinical, data management, regulatory and QA personnel regarding safety issues, as appropriate.
• Support Business Development (BD) activities including client presentations and accurate input for costings and proposals.
• Work with BD Costings and Proposals to provide time and cost estimates for new upcoming projects and staffing needs.
• Provide safety representation on project proposal teams and participate in business development meetings with potential new clients to ascertain their overall safety capabilities and needs.
• Provide input on all safety-related presentations for global use.
• Provide and discuss operational metrics on an ongoing basis to assist with continuous validation of the drug safety costing algorithms.
• Ensure efficient, effective, and economic operation of PSS including management of quality, regulatory compliance, and adherence to project budgets.
• Participate in discussions of planning and review of global/local practices.
• Provide safety data to support regulatory submission personnel for annual reports.
• Review and provide input on global Standard Operating Procedures (SOPs) and Work Instructions (WIs) involving safety, plans and documentation to ensure all PV and DSS units are aware of and work in accordance with ICH, FDA, and Asia-Pacific regulatory requirements.
• Provide review/assessment of requests for project-specific processes and SOP/WI deviations and seek senior management approval, prior to implementation by team.
• Interface with Information Technology (IT) regarding validation and utilization of safety databases.
• Ensure timely and appropriate reporting of expeditable adverse events to clients, regulatory authorities, ethics committees and investigators, as required.
• At times, execute routine quality review of AE reports and aggregate reports for other members of PSS ensuring that case processing and data quality meet global regulatory compliance needs, including audit support.
• Discuss project status at regular meetings with operations staff and ensure tracking sheets are updated appropriately.
• Ensure the effective collection of departmental metrics.
• Analyze metrics results and take necessary actions to ensure metrics are on target.
• Assess current and potential issues with quality and timeliness of work.
• Perform analysis of CQIs and CAPAs on regular basis and take necessary actions to correct trends in project delivery and quality issues.
• Discuss issues with and interpretation of regulatory reporting requirements with the Global Medical and Regulatory consultant.
• Discuss general medical safety issues.
• Maintain complete understanding of Fortrea 's safety database conventions and system functionality.
• Provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).
• Match available adequately trained staff resources to business needs.
• Ensure competency and skills are appropriate to projects and provide identified training needs.
• Ensure departmental working practices are in accordance with training and identify any areas requiring clarification or additional training.
• At project win stage, ensure that allocation of resources is predicted and managed for all projects.
• Apprise the Executive Director, PSS of resource requirements in advance of new projects or when additional coverage may be required in times of excess volume of work.
• Provide support to other members of PSS Management Team for periods of absence, vacation, and busy periods.
• Review metrics to evaluate current safety workload to forecast impact on future staffing needs.
• Participate in interviews, selection, and training of new PSS staff members.
• Generate and maintain a productive working environment for all teams in region.
• Provide effective direct management of PSS operations staff.
• Conduct regular staff meetings to provide a forum to facilitate good communication.
• Review and assess Performance Management and Development (Objectives and
• Development) Plan with direct reports as per CDS schedule.
• Build and maintain good drug safety relationships across functional units.
• Demonstrate Leadership Competencies on a consistent basis.
• Demonstrate company Values on a consistent basis.
• Review and approve Adverse Event Reporting Plans (AERPs), Reconciliation Plans, Randomization and Unblinding Plans, Endpoint Plans, Drug Safety Monitoring Board (DSMB) Charters, Postmarketing Surveillance Plans and any other client-specific safety plans ensuring optimal efficiency.
• Provide support and personnel for, and participate in, pre-contract audits, client audits, project team meetings and investigator meetings.
• Attend client meetings/teleconferences, as necessary.
• Ensure comparison of metrics collected vs. those costed for, and time billed to, identify out-of scope projects.
• Discuss corrective actions for out-of-scope projects to enable the preparation of change orders.
• And all other duties as needed or assigned.

Qualifications (Minimum Required):

• RN + 10 yrs. relevant experience
• BS/BA + 8 yrs. relevant experience
• MS/MA + 6 yrs. relevant experience
• PharmD + 4 yrs. relevant experience
• Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, Quality Assurance or Drug Safety.
• To be considered for this position, candidate must possess relevant experience as outlined above, plus at least 6 years of experience specifically in safety/AE processing) along with a minimum of 4 years supervisory experience (i.e., in project management or line management).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Language Skills Required:
• Speaking: English and local language.
• Writing/Reading: English and local language.

Experience (Minimum Required):

• At least 4 years line management and/or project management experience.
• Industry experience of which 6+years are relevant to 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.
• Work collaboratively with Safety Management's team.
• Leadership capabilities.
• Good communication.
• High degree of accuracy with attention to detail.
• Ensure client and global regulatory compliance.
• Will present and share useful business information across departments and functions.
• Anticipate/identify problems and takes appropriate action to correct.
• 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 event for both marketed and investigational products.
• Knowledge of ICH guidelines.
• Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.
• Knowledge of Medical Device reporting desirable.
• Knowledge of Periodic Safety Update Report (PSUR) desirable.
• Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
• Financially intuitive.
• Relevant experience includes experience in the pharmaceutical, biotechnology or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, Quality Assurance or Drug Safety.

Preferred Qualifications Include:

• Advanced degree preferred.

Physical Demands/Work Environment:

• Office environment or remote home-based office, as negotiated.
• Travel Requirement:
• Available for travel 15-20% of the time including overnight stays as necessary consistent with project needs and office locations.

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