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Job Overview:

Line manage PSS staff including performance reviews, human resource issues, and assist Senior PSS Management in assigning resources to projects.

Manage the overall PSS operations associated with products including the entire adverse events process; which may include safety data collected from clinical trials and/or post marketing settings (i.e., unsolicited reports) for specified projects.

Manage and process expedited 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.

Individual will be 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.

Summary of Responsibilities:

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.

Responsible for the line-management of individuals within team as well as 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.

Responsible for office management (schedules, desk assignments, business continuity planning, disaster recovery, etc.).

Escalate issues to Senior management as needed.

Participate in department/process improvement initiatives (identification and implementation).

Assist in development and continual improvement of departmental training curriculum.

Provide input on junior staff development.

Participate in interview process for new/replacement staff.

Act as a support person in the preparation of study-specific Safety monitoring plans for managers.

Assist in mentoring of PSS managers within the team.

May lead or assist with the management of PSS concerning project allocation and resourcing

Take a lead on ad-hoc strategic initiatives.

May lead or assist with the management of PSS concerning project allocation and resourcing.

Act as primary lead for 1-2 projects.

Oversee the individuals who manages receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is 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.

Determine expectedness/listedness against appropriate label.

Identifies 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 to 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 Fortrea project personnel, if required, within study specified timelines.

Oversee 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 Fortrea project personnel, if required, within study specified timelines.

Oversee individuals who manage 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 Fortrea’s safety database conventions and system functionality.

Maintain awareness of other client safety database conventions and functionality.

May prepare, but definitely provide oversight to the timely preparation of pharmacovigilance reports for products and safety issues, including Individual Case Safety 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.

Ensure that PV PSS teams work closely with the clinical operations and project management groups to ensure all drug safety activities are performed according to the regulatory and contractual requirements.

Support the appropriate Clinical Data Management (CDM) team(s) in the reconciliation of SAEs across safety and trials databases.

Contributes to the development and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms.

Consistently responsible for assisting with the set-up of, and the provision of data to, Safety Committees / Drug Safety Monitoring Boards.

Assist in the co-ordination of endpoint committees.

Participate and demonstrate leadership on projects which enhance team and/or division performance. This includes acting as lead contact for projects including global projects ensuring communication and processes are harmonized.

Prepare the team and participate in audits and or client inspections, either by the client or a regulatory agency.

Consistently contributes to solving technical and/or operational problems identified by program/project members.

Consistently proposes and executes innovative solutions which influence program/project direction.

Generation of monthly status, staff member performance and other project-specific reports ensuring the quality and accuracy of metrics and data provided.

Effectively draft/modify and deliver safety presentations. Serious Adverse Event reporting at investigator meetings. Client capabilities meetings, as appropriate. “Department Overview” to internal clients.

Attend client meetings and liaise with clients where appropriate.

Take a lead in strategic interactions and partnership with clients.

Ensure compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.

Responsible for ensuring the cascading relevant information from internal and external meetings to direct reports and appropriate colleagues.

Participate in Fortrea project teams and provide training about adverse event reporting to non-PSS personnel.

Train and mentor new employees overall in pharmacovigilance and regulatory reporting.

Maintain a comprehensive understanding of Fortrea PSS’ SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting, and pharmacovigilance

Possess knowledge of all other CDCS procedural documents that impact PSS.

Assist with the generation and review of SOPs, Work Instructions etc.

Responsible for SOP implementation within assigned team.

Oversee the maintenance of files regarding adverse event reporting requirements in assigned countries.

Assist in developing Operational metrics measuring PSS’ overall performance.

Manage the recruitment of new staff to PSS.

Build and maintain good PSS relationships across functional units.

Demonstrate role specific Competencies on consistent basis.

Demonstrate company Values on consistent basis.

Financial authority as it relates to personnel and projects.

Any other duties as assigned by management.

* The above job duties are completed by the staff as applicable, depending on the role they are assigned to.

And all other duties as needed or assigned.

Qualifications (Minimum Required):

For PharmD, a one-year residency of fellowship can be considered relevant experience.

Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Fluency in Japanese and English speaking, writing and reading required

Experience (Minimum Required):

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 PSS Management’s team.

Strong Leadership capabilities.

Excellent Communication.

Overall departmental resource Management.

Client Service Focus.

Ability to multitask and prioritize.

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.

Financially intuitive.

Knowledge of ICH guidelines.

Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance.

Deep understanding of Japanese GCP and GVP regulations

Experience in vendor management & oversight

Experience with local safety database configuration & migration

Experience in proposal development & budgeting, strategic client engagement, market intelligence & positioning

Preferred Qualifications Include:

Non-degree + 10 yrs. safety experience.

Associate degree + 8-9 yrs. safety experience.

Associate degree RN + 7-8 yrs. safety experience.

BS/BA + 6-7 yrs. relevant experience.

MS/MA + 5-6 yrs. relevant experience** (4-5 yrs. safety experience*).

PhD / PharmD + 3-4 yrs. relevant experience** (2-3 yrs. safety experience*) + 1-2 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.

At least 3-4 years line management and/or project management experience preferred.

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.

Physical Demands/Work Environment:

Office environment

Travel Requirements:

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.

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