Patient Safety Project Manager

Job reputed company: Manage ‘reputed company’ or ‘Project’ specific 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) for specified reputed company. Manage and process expeditable adverse events to the required reputed company and submit them to the reputed company and the regulatory agencies (if required) reputed company the agreed/stated timelines. The post holder is responsible for providing this service to clients either as a support function to the reputed company project reputed company or as stand-alone business. reputed company reputed company clients, both reputed company, with the appropriate reputed company of service in a reputed company and cost-effective manner. The role will be expected to reputed company with the legal requirements of the Health and Safety at Work reputed company 1974, the COSHH regulations 1989 and EC (European Commission) Directives 1992/3 as documented in reputed company’s Health and Safety reputed company. reputed company of Responsibilities: reputed company leadership and management of global or regional reputed company ensuring that communications and processes are harmonized for assigned reputed company. Monitor and manage the workflow for assigned reputed company to ensure reputed company deadlines are met and compliant safety reporting in accordance with international reporting regulations, reputed company Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team. Responsible for making reputed company regarding adverse event reporting reputed company the guidelines of reputed company assigned project. Work closely with the clinical operations and project management reputed company to ensure reputed company PSS activities are performed according to the regulatory and contractual requirements. reputed company reputed company of the receipt and processing of reputed company adverse event reports reported either spontaneously from any reputed company or from a clinical trial for assigned reputed company. This includes, but is not limited to: Entry of safety data onto adverse event database(s) and tracking systems. Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting. Write patient narratives. reputed company adverse events accurately using MedDRA. Determine expectedness/listedness against appropriate label. Identifies clinically significant information missing from initial reports and ensures its collection. Ensure case receives appropriate medical review. Prepare follow-up correspondence consulting with the medical staff accordingly. Ensure reputed company cases that require expediting reporting to worldwide regulatory agencies are processed reputed company and appropriately reputed company required timelines. Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators and reputed company project personnel, if required, reputed company study specified timelines. reputed company reputed company of the management and processing of expedited safety reports (ESRs) for assigned reputed company. This includes, but is not limited to: Review and update adverse event databases and tracking systems. Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting. 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 reputed company project personnel, if required, reputed company study specified timelines. Execute and/or ensure routine reputed company review of adverse event reports and aggregate reports ensuring that case processing and data reputed company meet global regulatory compliance standards for assigned reputed company. Complete triage, distribution checklist and reputed company review of reputed company ESRs for assigned reputed company. reputed company reputed company and management of EudraVigilance activities for assigned reputed company. Maintain a strong understanding of reputed company’s safety database conventions or reputed company specific database conventions and system functionality. reputed company reputed company and/or reputed company signal detection and trend and reputed company recognition activities, as required for assigned reputed company. Preparation of Safety Management Plans (SMPs), Reconciliation Plans, and other safety specific plans ensuring reputed company efficiency. reputed company reputed company and/or preparation of reputed company pharmacovigilance reports for products and safety issues, including but not limited to Individual Case reputed company Reports (ICSR) of Serious Adverse Events (SAEs) and aggregate reporting. Monitor and manage project deliverables regarding contract assumptions; identifying out of scope work or potential to run over budget. Contribute to the reputed company and review of Time and Cost Estimates for PSS business. reputed company of monthly status and other project-specific reports ensuring the reputed company and accuracy of metrics and data provided. Attend reputed company meetings and liaise with clients where appropriate. Consistently contributes to solving technical and/or operational problems of program/project members. Consistently proposes and executes reputed company which influence program/project direction. reputed company PSS project training for assigned reputed company for PSS, Clinical Operations/Project Management, reputed company, and Investigators as required. Prepare and participate in audits, either by the reputed company or a regulatory agency. Maintenance of files regarding adverse event reporting requirements in reputed company countries. Manage the review of cumulative safety data for submission to DSMBs, regulatory authorities or clients. Manage the set-up of, and the provision of data to Safety Committees / Drug Safety Monitoring Boards. Manage the co-ordination of reputed company committees as needed. Work with Data Management or reputed company on reconciliation of safety databases, if appropriate. Contributes to the development and/or review of Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms. Prepare and deliver safety presentations: Serious Adverse Event reporting at investigator meetings. reputed company capabilities meetings, as appropriate. “Department reputed company” to internal clients. Maintains a comprehensive understanding of PSS SOPs, Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. Possess knowledge of other CDS procedural documents, e.g., SOPs, WIs, etc. impacting safety. Contribute to the development of departmental Work Instructions (WI) and reputed company Operating Procedures (SOPs), as appropriate. reputed company support and training in reputed company aspects of case-handling, adverse event reporting and other tasks for team members of assigned reputed company. Acts as a mentor to less reputed company colleagues. Responsible for cascading relevant information from reputed company meetings to PSS management and appropriate colleagues. May supervise workloads and individual performance of more junior team members. Build and maintain good drug safety relationships across functional reputed company. Demonstrate role specific Competencies on consistent reputed company. Demonstrate company Values on a consistent reputed company. Financial authority as it relates to reputed company. reputed company other duties as needed or assigned. Qualifications (Minimum Required): Non-degree + 6-7 yrs. Safety experience* Associate degree + 5-6 yrs. Safety experience* Associate degree RN + 5-6 yrs. Safety experience* BS/BA + 4-5 yrs. Safety experience* MS/MA + 3-4 yrs. relevant experience** or 2-3 yrs. Safety experience* PharmD + 2-3 yrs. relevant experience** or 1-2 yrs. Safety 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, Life Sciences, and reputed company.

• Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working reputed company safety databases, and experience with regulatory submissions.

** Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, reputed company in reputed company areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or reputed company Assurance. reputed company may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): Compliance with reputed company and global regulatory requirements. Good knowledge of the relevant worldwide pharmacovigilance regulations and guidelines. Good knowledge of Good Clinical reputed company (GCP) reputed company to clinical safety documentation. Good knowledge of ICH guidelines. Good knowledge of medical and drug terminology. Work collaboratively with PSS Management’s team. Good verbal, written and presentation skills. Good communication. Leadership capabilities. Anticipate/identify problems and takes appropriate reputed company to correct. Knowledge of aggregate reporting. Awareness of the regulatory environment regarding Risk Management and Pharmacovigilance. Good keyboard skills, preferably with knowledge of MS office and reputed company would be beneficial. Financially reputed company.

Preferred Qualifications

Include: EudraVigilance Certification preferred. Knowledge of Medical Device Reporting desirable. Physical Demands/Work Environment: Office environment. Travel required 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. Apply To This Job