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. 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 Company’s Health and Safety Manual.
Summary of Responsibilities:
- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or solicited from a clinical trial including safety database entry, AE review, write patient narratives with coding, follow-up of missing information, listed assessment against appropriate label (for Marketed products, if applicable).
- Manage submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partner and Labcorp 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.
- May 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 a strong understanding of Labcorp’s safety database conventions or client-specific database conventions, as appropriate.
- Participate in signal detection, trend and pattern recognition activities, as appropriate.
- 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.
- Begin to participate and demonstrate leadership on projects which enhance team and/or division performance. This includes acting as a lead contact for projects including global projects ensuring communication and process harmonization.
- Work with Data Management or client on reconciliation of safety databases, if appropriate.
- Monitor workflow for assigned studies/programs to ensure all deadlines are met.
- Prepare and deliver safety presentations- o Serious Adverse Event reporting at Investigator meetings o Client capabilities meetings, as appropriate o “Department Overview” to internal clients.
- Maintains a comprehensive understanding of Labcorp PSS Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Participate or contribute to the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate.
- 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 and contribute towards training material development and updates.
- Contribute to preparation of 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.
- Assist PSS management to identify out of scope work.
- Actively participates in project team and client meetings and liaise with clients, where appropriate.
- Participate in client or regulatory audits, and support preparation if needed.
- Actively support quality issue resolution and implementation of process improvement initiatives/activities.
- 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 and assist in the co-ordination of endpoint committees, as required.
- Build and maintain good PSS relationships across functional units.
- Demonstrate role-specific Competencies and company values on a consistent basis.
- Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- Non-degree + 4 years of Safety experience* or 5-6 yrs of relevant experience**
- Associate degree + 3 years of Safety experience* or 4-5 yrs of relevant experience**
- BS/BA + 3 years of Safety experience* or 3-4 yrs of relevant experience**
- MS/MA + 2 yrs of Safety experience* or 3 yrs of relevant experience** PharmD + 2 yrs of Safety experience* or 3 yrs of relevant experience** For PharmD, a one-year residency of fellowship can be considered as 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.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
- Good verbal, written and presentation skills.
- Good communication.
- 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.
- 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.
Preferred Qualifications Include:
- Office environment or remote.
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