PURPOSE OF THE FUNCTION
* Serve as scientific expert and pharmacovigilance resource to external and internal partners within the country/region.
* Assess current processes to ensure adherence to local/regional safety regulatory requirements and, where needed, enhance and/or develop new processes while assuring consistency with global standards.
Preferred locations: Belgium, Switzerland
ROLES AND RESPONSIBILITIES:
* Act as point of contact for pharmacovigilance in the assigned country/region.
* Serve as the main contact point to support the local pharmacovigilance responsible person (LPVRP) in the assigned region, where applicable
* Support the Head of Regional PV in the harmonization of processes across the regions
* Support the Head of Regional PV in the management of innovation projects for increasing Regional Team efficiency.
* Establish and maintain the applicable pharmacovigilance system specific to the country/region
* Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the country/region.
* Provide support to responses to local pharmacovigilance related regulatory requests.
* Communicate global procedures and practices and monitor implementation.
* Lead the preparation of Pharmacovigilance Agreements (PVA) in collaboration with other departments
* In collaboration with the Regional PV Head, the GPS Ops and GPS QM Teams, review the documentation related to the concerned outsourced activities.
* Lead the PSMF data collection in the country/region when needed.
* Review documents pertinent to Non interventional studies and other organized data collection (Patient support programs and Market researches included), where applicable.
* Manage activities related to the proper intake and monitoring of unsolicited sources of safety information (eg, medical enquires, quality complaints, legal claims, social media posts) in the assigned country/region.
* Increase the visibility of the GPS team/function throughout argenx with focus on region.
* Participate in health authority interactions throughout the product life-cycle as needed.
* Closely collaborate with other functions including regulatory, medical, marketing, commercial, communications, quality, legal, as well as other teams as needed.
* Progress understanding and education of safety requirements for pharmacovigilance and other relevant regulations cross-functionally to ensure patient safety and compliance with local and global requirements.
* Develop relationships with cross functional teams and with business partners as it relates to adverse event reporting and other pharmacovigilance activities.
* Maintain an in-depth knowledge of local regulations, expectations and perform activities related to the interpretation and review of existing and evolving safety requirements.
* Identify, assess and communicate both internally and externally to GPS, all pharmacovigilance legislations updates that can impact the global GPS function and/or the Company overall (Pharmacovigilance intelligence).
* Actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the Quality team.
* Contribute to GPS issue management, recommend and implement action plans for mitigation.
* Identify opportunities to align PV standards globally.
* Maintain knowledge of the Company product portfolio and disease areas for marketed drugs and drugs in development.
* Contribute to the development and evaluation of Key Performance Indicators as related to pharmacovigilance in the country/region.
* Transparently communicate and/or escalate issues to GPS leadership as appropriate.
* Drive Continuous Improvement initiatives as needed.
* May perform other tasks as appropriate.
SKILLS AND COMPETENCIES:
* Excellent presentation skills with the ability to communicate complex issues clearly
* Excellent planning and organizational skills with ability to manage competing priorities
* Excellent oral and written communication skills
* Strong ability to motivate, influence, and collaborate with multidisciplinary teams
* Ability to work independently and in a global environment
* Understanding of safety business processes and systems for the collections of adverse events
* Problem solving, conflict resolution and critical thinking skills
* Demonstrated ability to author or contribute to complex documents
* Relevant computer skills, including proficiency with Microsoft Office Suite
* Fluency in written and spoken English
EDUCATION, EXPERIENCE AND QUALIFICATIONS:
* Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)
* At least 8-13 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities with at least 7 years in pharmacovigilance/drug safety
* Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents
* Knowledge of the drug development process, GXP quality and compliance requirements
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