Patient Safety Specialist- Gulf Cluster

Summary
An exciting opportunity to join our Patient Safety Team as a Patient Safety Specialist. We are welcoming UAE National Talents to apply for this role in which you will work towards supporting management of Patient Safety operational processes at Country Organization ensuring com-pliance with Novartis global and local procedures, national and international regulations/ standards/ guide-lines for vigilance of both marketed and investigational products (incl. drugs, food supplements and medical devices) from Novartis Group.
About The Role
Major Accountabilities:

• Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
• Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments.
• Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
• Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable.
• Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.
• Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
• Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
• Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
• Management and maintenance of all relevant Patient Safety databases.
• Ensure that relevant local literature articles are screened as appropriate.
• Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
• Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable.
• Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
• Ensure training and oversight of staff, as applicable.
• Manage and maintain efficient Patient Safety filing and archive system.
• Review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Research Organization (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible from the trial
• Drives the local execution of the Risk Management Plans (RMP) for all Novartis group products in Gulf Cluster:
  

Ensures training on RMP principles and RMP product specifics of Country Organization staff (incl. Sales/Marketing staff) involved in the implementation of the RMP
Supports the Drug Safety Responsible in the timely and compliant execution locally of the Pharmacovigilance activities defined in the RMP
Liaises with the other departments in the Country Organization such as Clinical Research Operations, Medical, Regulatory Affairs or Sales/Marketing to ensure alignment of all local functions in support of the RMP
Liaises with Sales/Marketing to ensure implementation of educational materials

• Liaises with Local Regulatory Affairs to ensure tracking of status of the RMP commitments implemented locally
• And other agreed tasks assigned by manager
  

Ideal Background
If you are a UAE National, hold a UAE Family Book and are passionate to join an organization that promotes an unbossed, diverse and flexible working environment, join us.
Education (minimum/desirable)
Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience
Languages

• Fluent in both written and spoken English
• Fluent in both written and spoken local language
  

Experience/Professional Requirement

• Knowledge of national and international regulations for pharmacovigilance
• Knowledge of pharmacological and medical terminology.
• Excellent communications, interpersonal and negotiation skills
• Quality and focus oriented
• Computer skills
• Additional educational requirements as may be mandated by national requirements
  

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.
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