Responsibilities:
• Manages and directs functions to comply with standard operating procedures, regulatory safety and pharmacovigilance and business technology quality standards in compliance with national and international regulations, such as relevant GxP guidelines and national and international legislations and regulations as well as aggregate safety reports in area of responsibility.
• Oversees evolving pharmacovigilance legislations and provides strategic direction for implementation of required changes to the global PV system; this may involve cross-functional approaches, including multiple interface functions.
• Establishes and ensures maintenance of regulatory required documents such as the PSMF, in line with international regulations, guidelines and internal standards.
• Supports the preparation and conduct of PV inspections and audits, as required and organizes or supports the back-office for regulatory PV inspections.
• Oversees/leads signal detection and management processes.
• Implements pharmacovigilance processes and ensures the uniform and timely analysis of safety data.
• Leads or contributes important initiatives to write new processes, or improve/optimize current processes in the functional area; acts as an expert on cross-functional teams for process optimization where the input of safety sciences is required.
• Provides day-to-day management support and direction to direct reports within the functional area.
• Contributes to study activities or post-marketing activities involving safety data and analysis.
• Develops and provides advanced analytical outputs to global teams to support analyses and decision making based on safety data.
• Development of new or enhancement of existing standard reports per company BT quality standards.
• Gathers, details, and documents user requirements in a way that is useful and meaningful to their business area experts and the technical team implementing the solution.
• Analyzes impact from changes to the database or changes in user/reporting requirements.
• Directs transfer of business requirements into technical solutions.
• Explores, analyzes and introduces data visualization tools to make complex analyses accessible to a broad audience.
• Business Process and/or Inspection SME/Leads for areas of responsibility.
• May provide medical evaluation of adverse event reports.
• Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary.
Qualifications:
• Bachelor degree, Medical Documentation, or equivalent in a life science discipline or Masters (or international equivalent) in science, medicine/health sciences, or epidemiology; or Bachelor degree (or international equivalent) in science, medicine/health sciences, or epidemiology with an increased experience requirement of an additional 3 years industry experience in a related role.
• 8-10 years' Pharmacovigilance experience in multinational pharmaceutical industry.
• 6+ years' experience in a leadership role.
• Expert knowledge of national/international pharmacovigilance regulations and PV processes.
• Knowledge of local/international relevant GxP regulations, IT standards and other relevant legislations such as legislations related to privacy protection.
• Experience with regulatory inspections.
• Experience in administration of complex data sets.
• Experience in project-managing CAPA and SOP development.
• Experience with GxP.
• Experience with relevant software applications.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
