Job Title: PV Liaison Senior Manager (USA), Regulatory affairs
Location: Candidate must go to NJ, Bridgewater office 2-3 times a week.
Supports the CSH 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.
Responsibilities
PV Liaison Senior Manager (USA):
o Supports the CSH 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
o Monitor ICSR compliance on a regular basis
o Collaborate with the Global Vendor to ensure accuracy of safety information
o Manage and oversee the case management in local Market Research programs; assist in case management in global Market Research programs
o 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
o 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
o Oversee the screening of local scientific / medical literature and manage relevant abstract/articles accordingly
Periodic Safety Report Management
o 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
o Perform training of the outsourced local PV activities
o Maintain all relevant documents related to the local PV activities, including job aids, training documents, activity trackers, etc.
o Maintain and monitor the quality of outsourced activities; ensure the activities are compliant to both internal and external timelines for the vendor
o Monitor KPI compliance of the vendor for the trained process
o Ensure that the escalated queries are handled
o Develop or adjust KPI for the newly training process
o 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
o Resolve any non-compliant issues with the vendor, if possible
o Raise the non-compliant issue and / or any KPI concerns of the vendor to the CSH
Safety Surveillance
o Perform signal surveillance for local products
o Review or follow up sentinel reports monthly for both global and local products
o Review or follow up with the observations of local products
o Follow up with the signals for the whole validation process and update the CSH accordingly
o Contribute to the development of local RMP, when applicable, with the support and validation of the Risk Management Expert
o Contribute to the development of PSRs, when applicable, with the support of GSO or LSO
o Track the actual implementation of additional Risk Minimization Measures (aRMMs)
o Support the CHC Global PV with local safety surveillance activities
o 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
o Responsible to support the preparation of PV inspections / audits
Compliance of Local Pharmacovigilance
o 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
o 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
o 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
o Maintain the Local Pharmacovigilance Safety Master File as per global policy
o Maintain and update the local quality documents
PV Regulatory Intelligence
o 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
o Screen and analyze national regulations, and forward any future/new/updated PV regulations to CSH
Assignment of PV Awareness training
o Collaborate with CHC GPV to ensure PV Awareness training is deployed in the learning management system according to local regulations on an annual basis
KEY WORKING RELATIONSHIPS
o CHC Country Safety Heads
o Regional PV Heads
o Global PV Operations Team
o Global Medical Safety Team
o QPPV Office
Regional Science Affairs Team
Qualifications we seek in you!
Competencies
Knowledge of national PV regulations and international regulations regarding safety requirements as well as industry standards
Leadership skills; problem-solve, prioritize, take initiative and meet challenges
Good written and verbal communication skills. Good level of speaking/writing English
Proficient in Words, PowerPoint, Excel, virtual meetings (such as Zoom).
Education
Bachelor’s degree or advanced degree in Health Science (e.g. BSN, RN, RPh, Pharm D).
Experiences
Experience with pharmacovigilance systems and safety related product management in both clinical development and marketed products
Appropriate experience with Regulatory Agency interactions and FDA inspections
Key Dimensions
Reports to US CSH
