Patient Safety Specialist

Major accountabilities:

• Manage 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.
• 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. Advocate for the needs of the affiliate at regional and global level to ensure that safety requirements are well supported
• 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 to other functions in the affiliate, to ensure their safe and effective use, specifically through implementation of risk management plans and risk minimization measures.
• 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), to ensure that they are well executed and satisfy quality and compliance expectations.
• 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.

Major Accountabilities

Local Pharmacovigilance Qualified Person/National Pharmacovigilance point of the contact: Serve as the Single Point of Contact or Deputy for Pharmacovigilance, ensuring 24-hour availability where required by local PV laws. Act as the National/Local Qualified Person or Local Contact Person for Pharmacovigilance, as defined by local regulations, and maintain direct communication with the Local Health Authority on Pharmacovigilance matters.

Communication flow: In collaboration with a (Senior) Patient Safety Manager and/or (Associate) Director Patient Safety Director of a region, ensure effective communication channels with local Affiliate(s), Patient Safety Regional lead(s), the EU-QPPV and third-party vendor(s). Ensure a two-way exchange of key information related to the Pharmacovigilance system within the local Affiliate(s), enabling PV system oversight and proactive risk mitigation in case of any occurred or potential non-compliance or safety issues.

Management of Safety Information

Case processing:

Supervise Local Case Management: Ensure effective supervision of all case management activities within the local Affiliate(s), maintaining high standards of accuracy and compliance (note: case management may be partially or fully outsourced to third-party vendors).

Report Adverse Events Promptly: Ensure all received Adverse Events are reported within 24 hours of receipt via the dedicated local adverse event generic email address. This guarantees timely processing of all Adverse Events by the Third-Party Vendor.

Identify and Oversee Local Sources of Adverse Events (AEs): Ensure comprehensive oversight of all local sources of Adverse Events (e.g., Medical Information, Call centers and sales representatives, Quality complaint management, Patient-Oriented Programs (POPs), Social Media Listening and Digital Engagement Assets, all kinds of Non-interventional studies and Interventional studies, Market research, Local business partners, Health Authorities etc.). Confirm that the reporting flow is correctly established through dedicated generic adverse event email address or the IVP Collect tool, ensuring timely processing of all Adverse Events by the Third-Party Vendor.

Coordinate with Third-Party Vendor(s) and process owners: Collaborate with third-party vendor(s) and process owner(s) to ensure seamless integration and execution of outsourced case management activities.

Ensure Regulatory Compliance Oversight: Guarantee that all case management activities comply with local regulatory requirements, including case submissions. In the event of detected non-compliances, collaborate with PS regional lead(s), process owner(s), Quality Assurance, and third-party vendors to implement timely corrections.

Product Quality Complaints: Maintain awareness of product complaints received within the local Affiliate(s). Ensure the exchange and reconciliation of product complaints associated with adverse events and escalate any suspicions of product quality issues that may be the root cause of adverse events according to established process.

Periodic reports: Collaborate with local, regional, and global teams to plan and ensure timely submission of periodic reports in compliance with local regulations. Coordinate with global functions, process owner(s) and third-party vendors to prepare and submit these reports.

Local Literature: Collaborate with local medical functions to periodically (at least once a year) identify relevant local journals for literature searches. Ensure that these journals are periodically screened by a third-party vendor in accordance with legislative requirements.

Support Business Activities: Collaborate in the setup of local programs and other local activities that may elicit adverse events and safety-relevant information. This includes implementing reporting pathways, data reconciliation, and source data verification for various programs (e.g., Patient Oriented Programs (POPs), social media Listening and Digital Engagement Assets, Interventional Studies, Non- Interventional Studies, Post-Authorization Safety Studies, Market Research etc.)

Sandoz product safety profiles and related actions

Health Authority Requests and Externally Generated Signals: Collaborate with all applicable stakeholders, third-party vendors, Regulatory Affairs (RA), Medical and other functions to ensure processes are in place to promptly and fully respond to safety-related requests from local Health Authorities and other externally generated safety-related responses, as applicable.

Awareness of Sandoz product safety profiles: Participate in governance meetings and stay informed about changes to the safety profiles of Sandoz products as determined by the Sandoz signal management process and other related processes. This includes any relevant subsequent actions, such as safety variations, additional risk minimization measures, or ad hoc safety measures.

Risk Management : Collaborate with local Affiliate(s), process owners, and third-party vendors to oversee and implement local Risk Management Plan (RMP) commitments and conduct effectiveness checks. Ensure comprehensive country-level oversight of the implementation of additional Risk Minimization Measures.

Ad hoc Safety Measures : Ensure comprehensive oversight of the implementation of ad hoc safety measures in the local Affiliate(s). This includes managing notifications of emerging safety issues, maintaining direct communication with healthcare professionals (DHCPs) and patients, enforcing urgent safety restrictions, and overseeing product recalls due to safety or quality concerns.

5. QMS and supporting processes

Local Procedures: With support of a (Senior) Patient Safety Manager and/or (Associate) Director Patient Safety Director of a region, ensure that local Pharmacovigilance requirements are fully met. Identify any specific requirements that may not be addressed by global procedures and communicate these to the Sandoz regional PS lead(s). Collaborate with the Sandoz regional PS lead(s), global process owners, Quality System Owner (QSO) to develop, update, and implement local procedures that supplement global Pharmacovigilance procedures, ensuring compliance with national regulations where needed.

Trainings: Ensure and oversee that all local internal and external stakeholders are adequately trained in baseline pharmacovigilance obligations.

Records management: Ensure that access to all records is maintained to oversee the flow of safety information at the local level. This includes archiving all safety documentation according to respective policies, guidance, and procedures.

Compliance Management: With support of a (Senior) Patient Safety Manager and/or (Associate) Director Patient Safety Director of a region, engage in compliance governance to oversee both internal and external compliance activities, including regulatory reporting, within established timelines. Ensure that any delayed safety cases or aggregate reports managed by third-party vendors are accurately documented, thoroughly investigated, and that root causes are identified and addressed through appropriate corrective and preventive actions. Audits and Inspections: Oversee local Pharmacovigilance inspections and audits. With support of a (Senior) Patient Safety Manager and/or (Associate) Director Patient Safety Director of a region, collaborate with key local stakeholders, including the Coun-try President, Quality Assurance, Regulatory Affairs, Medical, Commercial, Marketing, and Sales teams, to ensure the Affiliate’s PV system is fully prepared for pharmacovigilance inspections and audits. With support of a (Senior) Patient Safety Manager and/or (Associate) Director Patient Safety Director of a region, lead the local PV inspection/audit.

Deviation and CAPA: In collaboration with relevant internal or external stakeholders, identify and document relevant local Pharmacovigilance (PV) system deviations. Pro-actively collaborate in implementing corrective and preventative actions based on root cause analysis and CAPA plans. Serve as the local Patient Safety Subject Matter Ex-pert (SME) for PV system-related deviations and CAPAs in local Affiliate(s).

Local PSMF/PSSF : Support preparation and maintenance of the local Pharmacovigilance-lance System Master File (PSMF) and Pharmacovigilance System Summary File (PSSF) in accordance with local requirements, incorporating input from relevant local and global functions and third-party vendors. Pharmacovigilance Agreements (PVA): Provide input and review of local PVAs, ensuring appropriate language and content. Establish necessary controls for the formation, and the implementation of safety measures.

Local Regulatory Intelligence: Monitor and assess local pharmacovigilance regulatory requirements and updates, identifying gaps and impacts on existing local processes. Communicate any new or revised local pharmacovigilance legislation to relevant global pharmacovigilance teams as per the process, ensuring global assessments are conducted and necessary changes are implemented to maintain full compliance of the pharmacovigilance system.

Business Continuity Planning (BCP):

Ensure that appropriate local BCP plans are established and tested to maintain the flow of safety information during Local 24-Hour Accessibility: Ensure that effective local systems are in place to allow external stakeholders to report adverse events at any time.

6) Governance

Sandoz Patient Safety Governance: Collect and share relevant metrics on local Pharmacovigilance system, business volumes and performance. Participate in governance meetings at local, regional, and global levels to maintain oversight of the pharmacovigilance (PV) system’s performance and the safety profile of Sandoz products.

Notification and escalation: Communicate any PV system observations to relevant stakeholders, including local peers, regional PS lead(s), EU QPPV and third-party vendors, within the context of daily business interactions. If an observation cannot be re-solved or if an issue arises, escalate the matter formally using the established escalation procedures.

7) Projects

Participate in initiatives on local/regional/global level as Subject Matter Expert, or champion to contribute to business improvement for PS activities.

Key performance indicators:

• High Pharmacovigilance Compliance at Country Level:
• Regulatory Compliance Rate: Percentage of activities compliant with local regulatory requirements.
• Training Completion Rate: Percentage of staff who have completed mandatory pharmacovigilance training.
• Adverse Event Reporting Rate: Percentage of adverse events reported within the required timeframe.

2. Local Pharmacovigilance System Audit/Inspection Readiness:

Audit Preparation Score: Score based on a checklist of readiness criteria (e.g., documentation, staff preparedness).

Corrective Action Implementation Rate: Percentage of corrective actions from previous audits implemented on time.

3. Successful Audit/Inspection Outcomes:

Audit/Inspection Pass Rate: Percentage of audits/inspections passed without critical findings.

Time to Resolve Findings: Average time taken to resolve any findings from audits/inspections.

4. RMP Implementation:

RMP Compliance Rate: Percentage of local RMP commitments implemented on time.

Effectiveness Check Rate: Percentage of effectiveness checks conducted.

5. Deviation Management:

Deviation Resolution Rate: Percentage of deviations identified and resolved. CAPA Implementation Rate: Percentage of CAPAs implemented based on root cause analysis

.

6. Regulatory Update Implementation:

Update Implementation Rate: Percentage of new or revised regulations implemented.

Minimum Requirements:
Education and Work Experience:

• Experience: Minimum 2 years (for PS Specialist) in pharma industry in pharmacovigilance. if in addition Regulatory Affairs, Medical Affairs, (preferred)

  Regulatory Knowledge: Proven understanding of local pharmacovigilance requirements

  Process Knowledge: Advanced in pharmacovigilance processes, including compliance, databases, procedures, quality assurance, and training.

  Communication: Effective communication skills with various stakeholders.

  Audit and Inspection: Experience in pharmacovigilance audits and inspections desirable.

  Innovative Thinking: Ability for innovative and strategic thinking.

  · Skills: Negotiation, organizational, and interpersonal skills.

  Technical Proficiency: Proficiency in computer and IT systems.

• Professional qualifications in Health Care Sciences (e.g., Medical Doctor, Pharmacist)

Skills:

• Ability for innovative and strategic thinking.

• Negotiation, organizational, and interpersonal skills.

• Proficiency in computer and IT systems.

• Effective communication skills with various stakeholders

Languages :

• · Proficiency in English: Certified level of written and spoken English.

  · Local Language Skills: Good working knowledge of the local language.

  Additional Languages: Knowledge of other languages is desirable.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Skills Desired

Agility, Analytical Skill, Analytical Thinking, Computer Network, Cross-Functional Collaboration, Customer-Centric Mindset, Finance, Healthcare Sector Understanding, Health Economics, Health Technology Assessment (HTA), Key Account Management, Market Access, Process Management, Product Positioning, Public Affairs, Real World Evidence (RWE), Value Propositions, Waterfall Project Management