Senior Specialist, Country Patient Safety Responsible

Job Description

Major accountabilities:

• To support management of operational processes in ensuring compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products -Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
• Transcribe, translate (where required) and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
• Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications etc in cooperation with other departments -Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
• Work with other local/global PV associates to ensure accurate evaluation of safety data.
• Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third party contractor, if applicable.
• Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide update to global PVO organization.
• Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements.
• Management and maintenance all relevant assigned PVO databases, if applicable.
• Develop and update training materials for pharmacovigilance -Ensure support for and close-out of audits, corrective action plan activities and Health Authority inspections.
• Provide timely, relevant information to trial coordinators, CRAs and other Novartis staff -Distribution of marketing samples (where applicable)

Key Performance Indicators

• Adherence to Novartis policy and guidelines -Project and stakeholder feedback -Operational risk mitigation and audit/inspection findings -Quality and timely reporting of KPI and safety reports/updates -Results of audits/inspections

Minimum Requirements

Work Experience:

• Functional Breadth.
• Collaborating across boundaries.
• Operations Management and Execution.

Skills

• Databases.
• Employee Training.
• Filing (Documents).
• Pharmacovigilance.
• Reporting.
• Safety Science.

Languages

• English.