Process Lead PSS

Job Overview:

Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e. unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business. Responsible to provide all clients both internal and external with the appropriate quality of service in a safe and cost-effective manner. He/she 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 Companys Health and Safety Manual.

Summary of Responsibilities:

• Assist Team Lead/Project Manager/Service Delivery Manager in overall project Management Execute drug safety data management processes a combination of medical coding narrative writing peer review case follow-up report preparation and submission to regulatory authorities workflow management identify quality error trends conduct refresher training.
• Assist Team Lead/Project Manager/Service Delivery Manager in resource allocation within project.
• Assist and coordinate to ensure management volume peaks.
• Assist Team Lead/Project Manager/Service Delivery Manager in managing day to day operations.
• Submission of expedited Serious Adverse Event (SAE) reports to clients Regulatory Authorities Ethics Committees investigators 3rd party vendors Partners and Fortrea project personnel if required and 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 prioritised for processing and submission within the regulatory and/or study specific applicable timelines.
• Prepares timely pharmacovigilance reports for products and safety issues including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs) Annual IND reports European Annual Safety Reports (ASRs) Development Safety Update Report (DSUR) Periodic Reports (PRs) line listings and aggregate reports.
• Perform peer/independent QC of Safety reports as needed.
• Work with Data Management or client on reconciliation of safety databases if appropriate.
• Maintain a strong understanding of Fortreas safety database conventions or client-specific database conventions as appropriate.
• Assist in signal detection trend and pattern recognition activities as appropriate Monitor workflow for assigned studies/programs to ensure all the timelines are met.
• Participate in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics/data provided.
• Support/train less experienced safety staff in all aspects of case-handling adverse event reporting and other work as needed.
• Begin to prepare Safety Management Plans (SMPs) Reconciliation Plans and other safety specific plans under supervision.
• Responsible for making decisions regarding adverse event reporting within the guidelines of each specific project.
• Actively participates in project team and client meetings and liaise with clients where appropriate.
• Assist with proactive quality issue resolution and implementation of actions as needed.
• Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs) regulatory authorities or clients.
• Assist with the set-up of and the provision of data to Safety Committees/DSMBs Build and maintain good PSS relationships across functional units.
• Demonstrate role-specific Competencies and company values on a consistent basis.
• Assist in the co-ordination of endpoint committees as required.
• Any other duties as assigned.

Qualifications (Minimum Required):

• 10 yrs of relevant experience**
• Bpharm/Mpharm 10 yrs of safety experience* or relevant experience** PharmD 10 yrs of safety experience* or relevant experience**
• *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.
• Language Skills Required:
• Speaking: English and local language.
• Writing/Reading: English and local language.

Experience (Minimum Required):

• Good verbal and written communication skills and good presentation skills.
• Ability to interact and influence with line and middle management staff and external contacts on a functional and tactical level.
• High degree of accuracy with attention to detail.
• Functions as a team player.
• Ability to present and share useful business information across departments and functions.
• Ability to anticipate and identify problems and take appropriate action to correct them.
• Knowledge of medical and drug terminology.
• Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
• Knowledge of ICH Guidelines.
• Knowledge of Medical Device reporting desirable.
• Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
• Good knowledge and understanding of industry and R and D processes and objectives. Ability to work independently with minimal supervision.
• Good keyboard skills preferably with knowledge of MS office and Windows would be beneficial.
• Note: Refer to section III for experience requirements.

Preferred Qualifications Include:

• Degree preferred to be in one or more of the following disciplines:: Pharmacy Nursing Medical Sciences Life Sciences or related area.

Physical Demands/Work Environment:

• Office environment

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