Director, Regional Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the scientific authority and pharmacovigilance resource for both external and internal stakeholders within the designated country/region.

• Evaluate existing processes to ensure compliance with local and regional safety regulatory standards, and enhance or develop processes as necessary.

• Serve as the primary pharmacovigilance contact and a vital partner for leadership within the country/region.

• Collaborate effectively with quality assurance, legal, marketing, commercial, communications, and other relevant functions.

• Establish and uphold the pharmacovigilance system applicable to the country/region.

• Assist with regional process standardization and innovative projects.

• Foster awareness of and ensure compliance with pharmacovigilance responsibilities.

• Aid in addressing local regulatory requests related to pharmacovigilance.

• Communicate global procedures and oversee their implementation.

• Engage in FDA interactions throughout the product lifecycle.

• Supervise post-authorization requirements in the US.

• Review US aggregate reports and other pharmacovigilance documentation.

• Participate in the US Labelling Committee and oversee the review of US labelling.

• Lead the preparation of Pharmacovigilance Agreements.

• Review documentation pertaining to outsourced activities.

• Lead data collection for PSMF in the country/region as required.

• Review documents for non-interventional studies and organized data collection systems.

• Serve as a subject matter expert on GPS processes related to organized data collection.

• Enhance the visibility of the GPS team across argenx.

• Educate cross-functional teams regarding safety regulations and requirements.

• Cultivate relationships concerning adverse event reporting and pharmacovigilance operations.

• Stay informed about US regulations and evolving safety demands.

• Identify and relay updates on pharmacovigilance legislation.

• Participate in GPS audit and inspection readiness and management.

• Contribute to issue management and implement mitigation strategies.

• Seek opportunities to align with global pharmacovigilance standards.

• Maintain knowledge of the company's product offerings and related disease areas.

• Contribute to pharmacovigilance key performance indicators (KPIs).

• Escalate issues to GPS leadership when necessary.

• Drive initiatives for continuous improvement.

• Perform additional tasks as required.

⛳️ Requirements

• Master’s degree in pharmacy, nursing, healthcare, or a related life-science or technical discipline.

• PharmD or MD is advantageous.

• A minimum of 10-15 years of experience in the pharmaceutical or biotech industries, or within regulatory authorities.

• At least 8 years of experience in pharmacovigilance or drug safety.

• Familiarity with pharmacovigilance regulatory requirements and Good Pharmacovigilance Practices (GVP) guidance documents.

• Understanding of the drug development process, as well as GXP quality and compliance standards.

• Exceptional presentation skills, with the capacity to clearly communicate complex issues.

• Strong planning and organizational abilities, capable of managing competing priorities.

• Excellent oral and written communication skills.

• Proven ability to motivate, influence, and collaborate with multidisciplinary teams.

• Ability to work both independently and within a global setting.

• Understanding of safety business processes and systems for adverse event collection.

• Strong problem-solving, conflict resolution, and critical thinking abilities.

• Proven capability to author or contribute to complex documents.

• Proficient in Microsoft Office Suite.

• Fluent in both written and spoken English.

• Candidates must reside in the Eastern Standard Time (EST) zone.

🏝️ Benefits

• Short-term incentives program.

• Long-term incentives program.

• Equal opportunity for employment, free from discrimination.

• Inclusive work environment.