Director Regional Pharmacovigilance (US)

Purpose of the Function

Serve as scientific expert and pharmacovigilance resource to external and internal partners within the country/region.

Aim to 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 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.
• Support the Head of Regional PV in due diligence and integration activities as needed, when potential business partnerships or collaborations may take place.
• Establish and maintain the applicable pharmacovigilance system specific to the country/region.
• Promote increased awareness of and ensure compliance with pharmacovigivalence 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.
• Demonstrated experience using digital tools and automation to improve efficiency, visibility, and oversight across regional pharmacovigilance activities.
• Strong ability to motivate, influence, and collaborate with multidisciplinary teams.
• Strong ability to identify inefficiencies and redundancies and translate them into practical workflow improvements and automation opportunities.
• Strong ability to work independently and in a global environment.
• Strong ability to identify and assess both internally and externally to GPS, all pharmacovigilance legislations updates that can impact the global GPS function and/or the Company overall (Pharmacovigilance intelligence).
• Strong ability to identify and assess both internally and externally to GPS, all pharmacovigilance legislations updates that can impact the global GPS function and/or the Company overall (Pharmacovigilance intelligence).
• Strong ability to solve problems, resolve conflicts, and think critically.
• Strong ability to write and contribute to complex documents.
• Strong ability to support implementation of compliant digital solutions and process changes in alignment with quality, validation, and regulatory requirements.
• Experience with automation and dashboard tools (such as Power Automate, Power BI) and BPM tools (e.g., Visio, Signavio) or AI-enabled workflows is an advantage.
• 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 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.

Pay and Benefits

The annual base salary hiring range for this position is $192,000.00 - $264,000.00 USD.

Note: 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.