Patient Safety Manager

Job Description Summary

Lead and oversee pharmacovigilance activities within the local Affiliate(s), ensuring alignment with the Sandoz Pharmacovigilance (PV) System, Patient Safety (PS) organization and operating model, and associated Quality systems. This role is pivotal in guaranteeing that local safety procedures are comprehensive, effective, compliant, and seamlessly integrated within the cross-functional and global-regional-local framework. As a key member of the local Affiliate(s) organization, you play a pivotal role in promoting a comprehensive understanding of the PV system and ensuring adherence to local safety requirements. Your high visibility within the organization enables you to effectively advocate for the local Affiliate's needs at local, regional and global levels, ensuring robust support for all safety requirements

Job Description

Job Description
Main Responsibilities and Tasks:

• Lead pharmacovigilance activities in the Sandoz affiliate, in the context of the Sandoz Pharmacovigilance System, patient safety operating model, and associated quality system, to ensure that local safety procedures are comprehensive, effective, compliant and well embedded in the cross-functional and global-regional-local environment. This includes management of local Safety information like Adverse Events, PSURs, local literature and support of business to correctly set up programs and market research.

• Single point of contact: As defined by local regulations act as the National/Local Qualified Person or Local Contact Person for Pharmacovigilance in the country and act as the single point of contact with the Local Health Authority.

• Establish or participate in oversight mechanisms on safety activities, specifically those outsourced to vendors on behalf of the affiliate (local activities, such as in patient-oriented programs as well as core safety activities, and core safety activities, such as case handling and periodic report generation).

• Ensure the seamless flow of safety relevant information, within the affiliate, with local business partners and with regional hubs and 3rd party vendor in accordance with the Sandoz patient safety operating model.

• Maintain awareness on safety profiles of Sandoz products and provide safety expertise and support for all marketed and investigational products - drugs and combination products - to other functions in the affiliate including local implementation of RMP measures.

• Influence the affiliate organization as a key member of the affiliate organization with high visibility, to promote a thorough understanding of the pharmacovigilance system, adherence to safety requirements for local activities.

• Participate in the maintenance of the local quality management system, including training, records management, regulatory intelligence, audit and inspection readiness, in collaboration with local, regional and global functions, business partners and vendors.

• Deputize, The Manager Country Patient Safety Responsible can act as a temporary delegate for CPSR in other countries, in the context of a documented delegation plan, where the start, end and handover are described.

Minimum Requirements: 

 Education: Professional qualification in Health Care Sciences (e.g., Medical Doctor, Pharmacist or equivalent education, training, and experience) preferable.
 

Work Experience:

• Experience: Minimum 2-5 years in drug safety or pharmacovigilance (preferred)

• Leadership: Demonstrated leadership and achievement in all aspects of patient safety within a local/matrix environment in the pharmaceutical industry.

• Regulatory Knowledge: Extensive understanding of local and regional pharmacovigilance requirements, with the ability to address complex regulatory issues.

• Process Knowledge: Proficient in pharmacovigilance processes, including compliance, databases, procedures, quality assurance, and training. Proven ability to critically evaluate and integrate data from diverse areas/domains.

• Communication: Effective communication skills with various stakeholders.

• Audit and Inspection: Experience in pharmacovigilance audits and inspections is strongly preferable.

• Innovative Thinking: Demonstrated ability for innovative and big picture thinking.

• Skills: Strong planning, negotiation, organizational, and interpersonal skills.

• Technical Proficiency: Computer/IT systems literacy.

Languages :

• Proficiency in English: Fluent level of written and spoken English.

Skills Desired

Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Waterfall Project Management

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