Associate Director Pharmacovigilance

Associate Director Pharmacovigilance

argenx

Belgium or Switzerland

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 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;
• Establish and maintain the applicable pharmacovigilance system specific to the country/region;
• 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;
• 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;
• 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 8-13 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.