Manager Pharmacovigilance Quality and Compliance - Switzerland
- Under the leadership of the Senior Manager Pharmacovigilance EMEA and Swiss RPPV, this position provides oversight of the quality and compliance of the PhV organization through development and execution of global and local processes, standards, training programs, and compliance monitoring systems.
- Fosters a culture of continuous process improvement and identifies opportunities to further enhance quality and compliance.
- Provides support to implementation of the PhV system at local level and assists in achieving local compliance with global processes.
- Provides guidance to the Pharmacovigilance Operations and Safety Systems groups to identify and pursue global and long-term goals for the department.
- Assists with implementation of compliance relevant activities with PhV vendors and business partners and in the review and implementation of Pharmacovigilance Agreements / Safety Data Exchange Agreements as required. Participates in the audit and inspection process, including CAPA development/management.
Compliance and metrics, CAPAs, escalation, audits and inspections, processes (SOPs), training, local PhV systems, agreements, regulatory intelligence
- Assist in development, management and maintenance of global and local compliance monitoring systems, defining company performance measurement targets and metrics for external service providers, establishing processes, tools and tracking mechanism for company PhV deviations, ensuring appropriate corrective and preventive actions (CAPA) are in place, develop strategies to perform internal investigations of company PhV system, 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 establish and track CAPAs, as appropriate
- Manage and direct 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, proactively identify opportunities for process or systems-based improvements based on metrics and trends in root-cause analyses to improve efficiency and effectiveness. Lead subject matter experts in the modification of current SOPs and in the initiation of new procedural documents.
- Review company PhV related SOPs from other departments or affiliates, or from external service providers or Contract Research Organizations (CROs), to ensure compliance with corporate guidelines and applicable regulations
- Lead and manage preparation of response to Health Authorities inspection observations
- Participate in the internal PhV audit process, including development and management of CAPA plans and CAPA tracking,
- Oversee the development and provision of safety training materials for internal and external use and work with appropriate customers to determine frequency and venue of training sessions. Identify PhV training needs, develop job-specific training requirements and training curricula, and maintain company PhV training documentation and training tracking.
- This includes Adverse Event / Safety Information and company PhV process and safety systems training, as appropriate.
- Support in the maintenance of compliant regional and local PhV system at Affiliate level and support EU QPPV oversight of the local PhV system.
- Liaison with local PhV persons in dedicated countries. Maintenance of local PhV contact list for PSMF and distribution lists to external PhV vendors as required.
- Support to internal audit and HA inspection preparation,
- Maintenance/monitoring of Safety Intelligence (e.g. ICSR reporting requirements)
- Assist in managing the working relationships with PhV external service providers and business partners and in the review and implementation of Pharmacovigilance Agreements / Safety Data Exchange Agreements and activities associated with these agreements.
- Assist in the assessment of non-PhV vendors contract for the need of PhV clause and adverse event reporting training
- Manage the generation and maintenance of the Pharmacovigilance System Master File (PSMF) or similar document, as requested or participate to the development of specific sections of the PSMF related to local PhV system or compliance system, including maintenance of the PSMF Annexes
- Collaborate with other departments to ensure appropriate collection and handling of safety data, assist in the management of operational functions across Pharmacovigilance Operations and Safety Systems groups, as requested
- Collaborate with senior staff in PhV to achieve the objectives of the Department.
- Local Swiss Deputy Responsible Person for Pharmacovigilance including e.g. adverse handling (e.g. receipt, tracking, follow-up, reconciliation, submission), literature search, local SOP maintenance or development to ensure compliance with Swiss regulations and global policies and processes, ICSR submission via Swissmedic portal, etc
- Perform other duties as assigned
- B.A/B.S or equivalent experience in a drug safety or clinical environment with a minimum of 5 to 10 years of direct drug safety and pharmacovigilance experience including minimum of 3-4 years management and / or project management experience
- MS/MA degree in related discipline and eight years of related experience; or, equivalent combination of education and experience
- Experience in Biotech/Pharmaceutical industry required, experience in managing vendors/CROs required
- In depth pharmacovigilance knowledge, meeting facilitation and documentation skills required.
- Experience in audit management and CAPA writing processes and experience in process design, development, management and SOP writing
- Experience in collaborating with Business Partners required
- Understanding of Quality Management processes and compliance monitoring required
- Strong understanding of drug safety processes, FDA and other national or international regulations, and ICH guidelines required
- Guides the successful completion of major programs, projects, and/or functions
- Exercises independent judgment and identifies and implements methods, techniques, and evaluation of criteria to achieve results
- Demonstrates strong analytical/problem-solving skills, and develops technical and/or business solutions to complex problems
- Works on very complex problems where analysis of situations or data requires an in-depth evaluation of various factors; may work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles
- Demonstrates ability to manage multiple projects concurrently
- Possesses excellent business communication skills (oral and written)
- Demonstrates strong interpersonal/organizational and leadership skills as well as a 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