Responsibilities

• Leads or plays a key role in cross-functional teams for the review of safety data or safety-related reports
• Mentors and trains newer members of the functional area
• Ensures functions to comply with national and international regulations, such as GxP guidelines and/or any other relevant international and national legislation(s), regulations(s), and guidance(s) as well as company policies and procedures in area of responsibility
• Ensures direct reports to support and ensure QPPV’s oversight on the company’s Pharmacovigilance system, and identify, implement and monitor KPIs/KQIs across the company and manages cross functional CAPAs and other improvement activities on behalf of the QPPV.
• Performs impact assessment of evolving pharmacovigilance legislations and propose or provide strategic direction for implementation of required changes to the global PV system. This may involve cross-functional approaches, including multiple interface functions.
• Supports the preparation and conduct of PV and other GxP inspections and audits, as required and organize or support the back-office for regulatory PV inspections.
• Maintain/contribute to regulatory required documents such as the PSMF, in line with international and national regulations, guidelines and internal standards.
• Implements and supervise pharmacovigilance procedures as well as processes and ensures the uniform and timely processing and analysis of safety data to comply with regulatory requirements
• Ensure correct coding of all event and drug terms.
• Ensure inter- and intra-consistency for case evaluations.
• Participate in ICSR reporting compliance analysis and respective CAPA
• Together with Risk Management function develops and maintains Medical Concepts to support internal decision making and safety analyses for safety surveillance and provides expertise to pharmacovigilance and clinical development programs with regards to safety data/ SAE coding
• Manages regular MedDRA upgrades and provides impact analysis to RM physicians and ME
• Develop and provide 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 change in user/reporting requirements
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
• 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.
• May support/contribute to cross functional BT projects to fulfill GxP requirements and to improve inspection readiness
• May support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies