Director Regional Pharmacovigilance

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.

ROLES AND RESPONSIBILITIES

• Act as the main point of contact for pharmacovigilance and serve as a key partner to the general manager, regulatory affairs lead, and medical director in the assigned country/region.
• Closely collaborate with other functions including quality, legal, marketing, commercial, communications, as well as other teams as needed.
• Establish and maintain the applicable pharmacovigilance system specific to the country/region.
• 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.
• 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.
• Participate in FDA interactions throughout the product life-cycle, as needed.
• Have awareness and oversight on US Post-Authorization Requirements.
• Be part of the reviewer panel for US Aggregates (i.e., Periodic Adverse Experience Reports – PADERs) and other PV documents.
• Act as member of the US Labelling Committee. Review and suggest changes in the US Labelling.
• 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 organised data collection (Patient support programs and Market researches included), where applicable.
• Act as subject matter expert for the management of GPS processes and procedures related to Organized Data Collection Systems.
• Increase the visibility of the GPS team/function throughout argenx with focus on region.
• 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 US 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) in the country/region.
• 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 10-15 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities with at least 8 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
• Candidates must be located in the EST time zone to be considered for this role.