Auftragsdetails

Detailed Description

Safety Program Oversight & Project Leadership

• Provide oversight and direction of PV deliverables as a PV subject matter expert, encompassing all activities throughout the duration of a project/program. Continually seeks out ways to enhance client service experience both internally and externally.
• Prepare and present overall PV strategy and status at client meetings; communicate outcomes to PV management as appropriate.
• Oversee the development of detailed project/program specific Safety Management Plans, Work Instructions, and other documents as applicable (e.g., Reconciliation Plan). Serves as the primary reviewer/approver.
• Provide guidance to assigned clients on PV industry best practices, regulatory recommendations, and operational processes.
• Work with PV management to verify adequate project/ program resourcing.
• Develop and manage integrated PV project/program delivery timelines and risk assessments to report weekly progress.
• Train and mentor PV project team members on project/program specific tasks (i.e. case assessment and processing) and provide a working knowledge of the project/program assigned.
• Manage vendor(s) for outsourced services for assigned projects.
• Work in conjunction with Client Account Manager to verify all work performed is within scope of the contract and budget, and guide development of Change Orders to ensure project profitability.
• Perform other work-related duties as assigned
• Client implementation, including client meetings to explain our processes, review of core working practice, documents, and creation of client processing guidelines
• Case Management and Submissions Oversight
• Ensure all SAE and SUSARs are processed in accordance with client-specific requirements that fall outside of ProPharma Group SOPs and conventions.
• Perform medical review (as required) and/or case QC for assigned client(s).
• Liaise with safety review team to ensure data capture is sufficient for trending and aggregate analysis purposes.
• Develop client-specific data entry conventions as required and ensure staff training/compliance.
• Serve as a resource for Case Processing team for complex cases and escalated inquiries.
• Respond to inquiries from regulatory authorities regarding case information.
• Certify all applicable cross-reporting to regulatory/heath authorities, ethics committees, and investigative sites is handled in a compliant and consistent manner; troubleshoot any process gaps to create robust client-specific cross-reporting systems.

• Quality Assurance Support

• Serve as primary subject  matter  expert  during audits for  assigned client(s) and assumes ownership of response to any client-specific audit findings.
• File any deviations within the eQMS and follow CAPA processes to develop and implement corrective and preventative actions in collaboration with QA.
• Comply with all controlled document requirements and regulatory requirements to ensure quality deliverables.
• Perform monitoring of project/program-specific key performance indicators (KPIs).
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
• Collaborate with QPPV and/or LPPV as necessary.

   

• Maintain understanding of and ensure compliance with SOPs, WIs, global drug/biologic/device regulations, GXP,  ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process.
• Working knowledge of PV Systems, such as Oracle Argus Safety, ARISg, or other safety databases.
• Proficient in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), SharePoint (or other management/ shared content/ workspace) and internet.
• Excellent internal and external customer service skills.
• Strong verbal, written and interpersonal communication skills.
• Strong organization and prioritization skills with attention to detail.
• Strong problem-solving skills across a broad range of complexities.
• Able to work independently and collaboratively in a multidisciplinary team.
• Able to occasionally work extended and/or flexible schedule to meet client requirements.
• Minimal travel may be required (up to 10%).