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
KEY WORKING RELATIONSHIPS
CHC Country Safety Heads
Regional PV Heads
Global PV Operations Team
Global Medical Safety Team
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
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Other
Industries
IT Services and IT Consulting
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