PV Liaison Manager Job at Cmed
Cmed is seeking an PV Liaison Manager for this client dedicated opportunity with 3-5 years of PV expereince that can be onsite in the Bridgewater, NJ site 2 days per week.
PV Liaison Manager will support the US Country Safety Head in all PV related activities at the country level, including but not limited to management of cases, periodic safety reports, activities of local vendor, safety surveillance of marketed products, audits / inspections, compliance of Local Pharmacovigilance, PV Regulatory Intelligence and PV awareness training.
Case Management
Monitor ICSR compliance on a regular basis
Collaborate with the Global Vendor to ensure accuracy of safety information
Manage and oversee the case management in local Market Research programs; assist in case management in global Market Research programs
Create or collaborate with the relevant departments to develop deviations which are related to late submissions to FDA; ensures correction / preventive actions are in place
Monitor continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to Global PV Operations and subsequently to external stakeholders, such as HAs, partners
Oversee the screening of local scientific / medical literature and manage relevant abstract/articles accordingly
Periodic Safety Report Management
Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with the relevant departments, not limited to Global PV, and RA departments to the planning for PSRs
Training and Oversight of Local Vendor Activities
Perform training of the outsourced local PV activities
Maintain all relevant documents related to the local PV activities, including job aids, training documents, activity trackers, etc.
Maintain and monitor the quality of outsourced activities; ensure the activities are compliant to both internal and external timelines for the vendor
Monitor KPI compliance of the vendor for the trained process
Ensure that the escalated queries are handled
Develop or adjust KPI for the newly training process
In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), manage contract/work order with local service provider, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviations
Resolve any non-compliant issues with the vendor, if possible
Raise the non-compliant issue and / or any KPI concerns of the vendor to the CSH
Safety Surveillance
Perform signal surveillance for local products
Review or follow up sentinel reports monthly for both global and local products
Review or follow up with the observations of local products
Follow up with the signals for the whole validation process and update the CSH accordingly
Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert
Contribute to the development of PSRs, when applicable, with the support of GSO or LSO
Track the actual implementation of additional Risk Minimization Measures (aRMMs)
Support the CHC Global PV with local safety surveillance activities
Ensure that PV unit is involved in reviewing relevant safety sections of local documents, owned by other affiliates entities, such as labelling, contracts with third parties and local study protocols.
Inspections and Audits
Responsible to support the preparation of PV inspections / audits
Compliance of Local Pharmacovigilance
Ensure that local PV activities are performed in compliance with the Global PV policies, as well as global, regional, and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country
Secure that for all global/local Business Partner agreements, requiring safety provisions, a local SDEA or PV Clause is set-up, implemented and maintained as appropriate
Ensure oversight of changes to global quality documents so that processes can be implemented in a timely manner and, when applicable, create local quality documents aligned with the global procedures
Maintain the Local Pharmacovigilance Safety Master File as per global policy
Maintain and update the local quality documents
PV Regulatory Intelligence
Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Support Programs, Market Research, Managed Access Program etc), and company sponsored digital media as well as the reconciliation process as applicable
Screen and analyze national regulations, and forward any future/new/updated PV regulations to CSH
Assignment of PV Awareness Training
Collaborate with CHC GPV to ensure PV Awareness training is deployed in the learning management system according to local regulations on an annual basis
For more information on Cmed recruitment and consideration for other opportunities, please review the recruitment statement on our careers page ( https://www.cmedresearch.com/careers/ ).
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Cmed HR or Recruitment Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Cmed may directly contact for employment application.
Please Note :
www.bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
PV Liaison Manager will support the US Country Safety Head in all PV related activities at the country level, including but not limited to management of cases, periodic safety reports, activities of local vendor, safety surveillance of marketed products, audits / inspections, compliance of Local Pharmacovigilance, PV Regulatory Intelligence and PV awareness training.
Case Management
Monitor ICSR compliance on a regular basis
Collaborate with the Global Vendor to ensure accuracy of safety information
Manage and oversee the case management in local Market Research programs; assist in case management in global Market Research programs
Create or collaborate with the relevant departments to develop deviations which are related to late submissions to FDA; ensures correction / preventive actions are in place
Monitor continuously in-coming communication to ensure the detection and appropriate management of in-coming PV data (ICSRs and other safety related information) to report them in timely manner to Global PV Operations and subsequently to external stakeholders, such as HAs, partners
Oversee the screening of local scientific / medical literature and manage relevant abstract/articles accordingly
Periodic Safety Report Management
Handle appropriately local periodic reports, including periodic safety reports (PSRs) and periodic reviews, and contribute together with the relevant departments, not limited to Global PV, and RA departments to the planning for PSRs
Training and Oversight of Local Vendor Activities
Perform training of the outsourced local PV activities
Maintain all relevant documents related to the local PV activities, including job aids, training documents, activity trackers, etc.
Maintain and monitor the quality of outsourced activities; ensure the activities are compliant to both internal and external timelines for the vendor
Monitor KPI compliance of the vendor for the trained process
Ensure that the escalated queries are handled
Develop or adjust KPI for the newly training process
In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), manage contract/work order with local service provider, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviations
Resolve any non-compliant issues with the vendor, if possible
Raise the non-compliant issue and / or any KPI concerns of the vendor to the CSH
Safety Surveillance
Perform signal surveillance for local products
Review or follow up sentinel reports monthly for both global and local products
Review or follow up with the observations of local products
Follow up with the signals for the whole validation process and update the CSH accordingly
Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert
Contribute to the development of PSRs, when applicable, with the support of GSO or LSO
Track the actual implementation of additional Risk Minimization Measures (aRMMs)
Support the CHC Global PV with local safety surveillance activities
Ensure that PV unit is involved in reviewing relevant safety sections of local documents, owned by other affiliates entities, such as labelling, contracts with third parties and local study protocols.
Inspections and Audits
Responsible to support the preparation of PV inspections / audits
Compliance of Local Pharmacovigilance
Ensure that local PV activities are performed in compliance with the Global PV policies, as well as global, regional, and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned country
Secure that for all global/local Business Partner agreements, requiring safety provisions, a local SDEA or PV Clause is set-up, implemented and maintained as appropriate
Ensure oversight of changes to global quality documents so that processes can be implemented in a timely manner and, when applicable, create local quality documents aligned with the global procedures
Maintain the Local Pharmacovigilance Safety Master File as per global policy
Maintain and update the local quality documents
PV Regulatory Intelligence
Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Support Programs, Market Research, Managed Access Program etc), and company sponsored digital media as well as the reconciliation process as applicable
Screen and analyze national regulations, and forward any future/new/updated PV regulations to CSH
Assignment of PV Awareness Training
Collaborate with CHC GPV to ensure PV Awareness training is deployed in the learning management system according to local regulations on an annual basis
For more information on Cmed recruitment and consideration for other opportunities, please review the recruitment statement on our careers page ( https://www.cmedresearch.com/careers/ ).
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Cmed HR or Recruitment Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Cmed may directly contact for employment application.
Please Note :
www.bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.