Director Regional Pharmacovigilance

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

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 (Ie 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.

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The annual base salary hiring range for this position is $192,000.00 - $264,000.00 USDNote: If the posted hiring range does not apply to your work location, the recruiter will share the locally applicable annual base salary hiring range, provided in your country's currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location.

This job is eligible to participate in our short-term and long-term incentives program.

The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

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Originally posted on Himalayas