(Senior)Manager/Associate Director Pharmacovigilance Quality, Training and Standards

Job content

For the expansion of our Pharmacovigilance team, argenx is looking for a (Senior) Manager/ Associate Director Pharmacovigilance Quality, Training and Standards , who will maintain and oversee the daily activities regarding the pharmacovigilance quality system. This position will also maintain a comprehensive pharmacovigilance training program and serve as the cross functional point of contact for pharmacovigilance training needs.

Key Accountabilities/Responsibilities

Quality and Standards

• Regularly review key performance indicators (KPIs) and internal metrics. Prepare and maintain summaries and communicate regularly to GPS management
• Support the development of and monitor compliance with pharmacovigilance agreements (PVAs), Safety Data Exchange Agreements (SDEAs) and other agreements as applicable with business partners
• Represent GPS in internal audits and regulatory inspections
• Coordinate and prepare GPS responses to audit and inspection findings
• In coordination with the QA department, lead global GPS audit and inspection readiness activities
• Identify internal deviations, perform root cause analyses and in collaboration with QA lead or support the implementation of corrective or preventive actions as appropriate
• Identify GPS compliance, quality or training related risks and escalate to GPS management
• Monitor the status of and compliance with GPS Standard Operating Procedures (SOPs) and other controlled documents. As needed author, review or otherwise contribute to these documents
• Perform impact analysis for pharmacovigilance compliance strategies and other pharmacovigilance processes
• Regularly liaise with the QA Department regarding GPS quality and compliance requirements and deliverables
  
  

Training

• Develop, maintain and deliver an effective and comprehensive pharmacovigilance training program
• Monitor, maintain and update the GPS training curricula
• Work closely with key stakeholders to implement pharmacovigilance training across the company globally and to expand to external partners as applicable
• Identify the need for additional pharmacovigilance training needs, prepare and conduct training as applicable
• Participate in cross-functional teams and initiatives
• Perform other tasks as required to assist in departmental activities
  

Desired Skills And Experience

• Excellent planning and organizational skills
• Excellent oral and written communication skills
• Solution oriented with ability to prioritize and work independently
• Excellent presentation skills with the ability to communicate complex issues clearly
• Demonstrated ability to author and contribute to complex documents
• Ability to motivate, influence, and collaborate with multidisciplinary teams
• Relevant computer skills, including proficiency with Microsoft Office
• Fluency in written and spoken English
• Bachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (Master’s degree or PharmD is a plus)
• At least 3 years of experience in the pharmaceutical/biotech industry with at least 2 years in pharmacovigilance/drug safety (global experience is a plus)
• Experience in training-related field and scientific/medical writing is a plus
• Knowledge of pharmacovigilance regulatory requirements and GVP guidance documents
• Knowledge of GXP quality and compliance requirements, processes and measures
  

Offer

• A competitive salary package with benefits;
• A work environment in a human-sized, dynamic, rapidly growing biotech company