Director Regional Pharmacovigilance

argenx

22h•$192,000 - $264,000

About The Position

Serve as a scientific expert and pharmacovigilance resource to internal and external partners within an assigned country or region. Assess existing processes for compliance with local and regional safety regulations, and develop or enhance processes as needed while maintaining consistency with global standards. The role is the main pharmacovigilance contact for the assigned region and partners closely with regional leadership and cross-functional teams. The Director supports regional process harmonization and efficiency initiatives, promotes awareness and compliance with pharmacovigilance obligations, and supports regulatory responses, FDA interactions, and oversight of US post-authorization requirements. Responsibilities also include reviewing safety and labeling documents, leading pharmacovigilance agreement preparation, coordinating documentation for outsourced activities, supporting pharmacovigilance system readiness for audits and inspections, and contributing to issue management and continuous improvement. The role requires maintaining knowledge of US safety regulations and evolving requirements, communicating relevant legislative changes, educating cross-functional teams, and building relationships with business partners on adverse-event reporting and other pharmacovigilance activities. Candidates must be located in the EST time zone.

Requirements

Master’s degree in pharmacy, nursing, healthcare, another life-science field, or a technical field.
At least 10–15 years of experience in the pharmaceutical or biotech industry or at regulatory authorities, including at least 8 years in pharmacovigilance or drug safety.
Working knowledge of pharmacovigilance regulatory requirements and Good Pharmacovigilance Practices (GVP) guidance documents.
Knowledge of the drug development process and GxP quality and compliance requirements.
Excellent presentation skills and ability to communicate complex issues clearly.
Excellent planning and organizational skills, including the ability to manage competing priorities.
Excellent oral and written communication skills.
Ability to motivate, influence, and collaborate with multidisciplinary teams.
Ability to work independently in a global environment.
Understanding of safety business processes and systems for collecting 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.
Must be located in the EST time zone.

Nice To Haves

PharmD or MD.

Responsibilities

Serve as the main pharmacovigilance point of contact and key partner to the general manager, regulatory affairs lead, and medical director in the assigned country or region.
Collaborate with quality, legal, marketing, commercial, communications, and other relevant functions.
Establish and maintain the pharmacovigilance system applicable to the country or region.
Support the Head of Regional PV in harmonizing regional processes and managing innovation projects to improve regional team efficiency.
Promote awareness of and compliance with regional pharmacovigilance obligations.
Support responses to local pharmacovigilance-related regulatory requests.
Communicate global procedures and practices and monitor their implementation.
Participate in FDA interactions throughout the product life cycle as needed.
Maintain awareness and oversight of US post-authorization requirements.
Review US aggregate safety reports, including Periodic Adverse Experience Reports (PADERs), and other pharmacovigilance documents.
Serve on the US Labelling Committee and review and suggest changes to US labeling.
Lead preparation of Pharmacovigilance Agreements (PVAs) in collaboration with other departments.
Review documentation related to outsourced activities with the Regional PV Head, GPS Operations, and GPS Quality Management teams.
Lead country- or region-level Pharmacovigilance System Master File (PSMF) data collection when needed.
Review documents related to non-interventional studies and other organized data collection, including patient support programs and market research, where applicable.
Serve as a subject matter expert for GPS processes and procedures related to Organized Data Collection Systems.
Increase the visibility of the GPS team and function across argenx, with a focus on the region.
Promote cross-functional understanding and education regarding safety requirements and relevant regulations to support patient safety and compliance.
Develop relationships with cross-functional teams and business partners regarding adverse-event reporting and other pharmacovigilance activities.
Maintain in-depth knowledge of US regulations and expectations, and interpret and review existing and evolving safety requirements.
Identify, assess, and communicate pharmacovigilance legislative updates that may affect the global GPS function or the company.
Participate in GPS audit and inspection readiness, support, and management with GPS Quality Management and Quality teams.
Contribute to GPS issue management and recommend and implement mitigation action plans.
Identify opportunities to align pharmacovigilance standards globally.
Maintain knowledge of the company’s product portfolio and disease areas for marketed and developing drugs.
Contribute to the development and evaluation of pharmacovigilance key performance indicators for the country or region.
Communicate and escalate issues to GPS leadership as appropriate.
Drive continuous improvement initiatives as needed.
Perform other tasks as appropriate.