Manager / Country Patient Safety Responsible Poland

Job Description Summary

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz!

 

Job Description

Main Responsibilities and Tasks:

Leadership: Build strong relationships with relevant functions in the affiliate organization (including but not limited to regulatory affairs, medical affairs, quality assurance, marketing and sales, clinical development and others), in collaboration with the Director Patient Safety HUB Europe and 3rd party vendors.

Communication flow: In collaboration with the Sandoz regional Hubs and the 3rd party vendor operational hubs, ensure that communication flows for safety processes including any local sources of safety data and safety issues are identified and implemented.

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(ies) and act as the single point of contact with the Local Health Authority.
 

Management of Safety Information:

• Management of Adverse Events: Ensure the local management of adverse event information, Identification of sources of adverse event information, Maintaining oversight on case content and reporting.
• Management of Periodic reports: planning and oversight
• Management of Local Literature in collaboration with 3rd party vendor
• Support business in the set-up of programs and any other activities that may elicit adverse event and other safety relevant
   

Sandoz product safety profiles and related actions:

• Health Authority Requests (and other externally generated signals): In collaboration with 3rd party vendor, Regulatory Affairs (RA) and other functions, ensure processes are in place to answer fully and promptly any safety related requests from Local Health Authorities.
• Awareness of Sandoz product safety profiles
• Risk Management: Cooperation and oversight of the implementation of local RMP commitments and effectiveness checks
• Ensure readiness to implement ad hoc safety measures.

QMS and supporting processes:

• Local Procedures: Ensure the local Pharmacovigilance requirements are met. Where required, implement local procedures to supplement PS global procedures.
• Trainings of local internal and external stakeholders on pharmacovigilance obligations.
• Monitor internal compliance for local processing and external compliance.
• Audits and Inspections: In cooperation with the 3rd party vendor, partner functions and management maintain audit/inspection readiness and manage local Pharmacovigilance audit/inspection.
• Deviation and CAPA management
• PV Agreements
• Regulatory Intelligence.
• Local 24hr accessibility: ensure that suitable local systems are in place that will allow concerned external stakeholders to report adverse events anytime.

Ideal Background

Education (minimum/desirable):

• Medical Doctor, Pharmacist or equivalent education, training, and experience.

Languages:

• Certified level of written and spoken English.
• Good working knowledge of Hebrew.
• Knowledge of other languages (desirable).  

Experience/Professional Requirement:        

• Minimum 5 years’ experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry.
• Minimum 2-3 years of demonstrated leadership and accomplishment in all aspects of patient safety in a local/matrix environment in the pharmaceutical industry.
• Extensive knowledge of regional and local requirements relating to PV. Ability to solve complex regulatory issues and requirements.
• Working knowledge of PV-processes, covering compliance, databases, procedures, QA, training. Proven ability to critically evaluate and integrate data from a broad range of areas/domains. Ability to effectively communicate with different stakeholders.
• Experience in PV audits and inspections.
• Demonstrated track record to successfully lead/work  in  interdi