Specialist, Pharmacovigilance Quality and Compliance - Switzerland
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- Under the leadership of the Senior Manager Pharmacovigilance EMEA and Swiss RPPV, this position provides the support necessary to ensure the oversight of the quality and compliance of the PhV organization.
- Assists in the development and execution of global and local processes, training programs, and compliance monitoring systems.
- Fosters a culture of continuous process improvement, provides support to implementation of the PhV system at local level and assists in achieving local compliance with global processes.
- Assists with implementation of compliance relevant activities with PhV vendors and business partners, with the review and implementation of Pharmacovigilance Agreements / Safety Data Exchange Agreements as required.
- Participates in the audit and inspection process, including CAPA tracking.
Compliance and metrics, CAPAs, escalation, audits and inspections, processes (SOPs), training, local PhV systems, agreements, regulatory intelligence
Duties and Responsibilities
- Assist in development, management and maintenance of global and local compliance monitoring systems, in establishing processes, tools and tracking mechanism for the company PhV deviations, in ensuring appropriate corrective and preventive actions (CAPA) are in place.
- Ensure tracking of compliance data and metrics
- Alert senior management of significant deficiencies in quality and compliance standards and work with internal company staff, external vendors, and business partners to track CAPAs, as appropriate
- Support the periodic review of existing procedural documents (e.g., policies, standard operating procedures (SOPs), work instructions (WIs), forms) relative to the pharmacovigilance function within the company, assist in the identification of opportunities for process or systems-based improvements based on metrics and trends in root-cause analyses to improve efficiency and effectiveness.
- Support the review of company PhV related SOPs from other company departments or affiliates, or from external service providers or Contract Research Organizations (CROs), to ensure compliance with corporate guidelines and applicable regulations
- Support preparation of response to Health Authorities inspection observations
- Participate in the internal PhV audit process, including CAPA tracking,
- Support the development and provision of safety training materials for internal and external use.
- Maintain company PhV training documentation and training tracking.
- Support the maintenance/monitoring of Safety Intelligence (e.g. ICSR reporting requirements)
- Maintain xEVMPD data as required, in close collaboration with EU QPPV
- Collaborate with senior staff in PhV to achieve the objectives of the Department.
- Support Pharmacovigilance activities at the Swiss Affiliate including e.g. adverse handling (e.g. receipt, tracking, follow-up, reconciliation, submission)
- Perform other duties as assigned
- Contribute positively to a strong culture of business integrity and ethics
- Act within compliance and legal requirements as well as within company guidelines
- B.A/B.S or equivalent experience in a drug safety or clinical environment with a minimum of 3 years of direct drug safety and pharmacovigilance experience
- MS/MA degree in related discipline and 3 years of related experience; or, equivalent combination of education and experience
- Experience in Biotech/Pharmaceutical industry required
- Good pharmacovigilance knowledge, meeting facilitation and documentation skills required.
- Experience in SOP writing
- Understanding of Quality Management processes and compliance monitoring required
- Good understanding of drug safety processes, FDA and other national or international regulations, and ICH guidelines required
- Demonstrates analytical/problem-solving skills, works on problems where analysis of situations or data requires an evaluation of various factors
- Demonstrates ability to manage multiple activities concurrently
- Possesses good business communication skills (oral and written)
- Demonstrates interpersonal/organizational skills as well as a strong team-oriented approach
- Possesses ability to work with autonomy
- Applies attention to detail and practices good time management skills
- Possesses strong computer skills in drug safety applications, Microsoft Office Suite (Word, Excel, and PowerPoint)
- Must be fluent in English and comfortable in a fast-paced, demanding work environment
- Maintains high ethical standards, including a commitment to company values and behaviors