Patient Safety Manager

• Single point of contact: Act as the Local Qualified Person for Pharmacovigilance/ Local PV Responsible Person in Novartis Country Organization, as defined by local regulation and applicable legislation in WA. Local operational activities:
• Set up, update, and implement local procedures to ensure compliance with PS global procedures and national requirements.
• Case Processing (triage/ documentation; translation; data-entry; follow-up activities and archive, as applicable).
• Expedite ICSR reporting and aggregate reporting (PSUR, DSUR, ASR) in relation to quality, accuracy, completeness and timelines, as applicable.
• Ensure local PS-related RMP commitments are executed and properly documented.
• Training of MAH personnel in relation to PV.
• Local Licensing agreements.
• Pre- and post-authorisation safety studies, with appropriate PS input as required.

• Act as a key partner who provides input, during the process of establishing local programs (ex. POPs, DEAs; SM/SML, etc.): comments on proposals for vigilance language, content, and establishment of necessary controls on collection and reporting of adverse event information.
• Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract.
• Ensure that relevant local literature articles are screened as appropriate.
• Supervision of management and maintenance all relevant PS databases.
• Ensure timely preparation and submission of KPI reports on AE reporting or AE follow-up including identification of root cause(s), development and implementation of corrective and preventative action(s) as needed.
• Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract.
• Supports on monitoring and assessment of performance of PV third parties and local partners in line, with the applicable regulations, agreements and standard operational/ working procedures in place. In collaboration with QA and Vendor Management functions, ensures corrective and/or preventive actions are implemented in case contractual commitments are not met, as applicable.
• Monitor national pharmacovigilance regulations and provide update to global PS organization.
• Supports in a promptly answer to any safety related requests from Local Health Authorities in the country.
• Ensure support for and close-out of audits, corrective action plan, investigation, self-assessment and Health Authority inspections.
• Mentors less experienced staff, maintaining a professional network of key contacts and role model Novartis values and behaviors.
• Supports on cluster tasks assigned by reporting manager

Minimum Requirements:
Work Experience:

• Minimum 3 years’ experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry.

Skills:

• Good knowledge of local requirements relating to PV and RMPs
• Working knowledge of PV-processes, covering compliance databases, procedures, QA, training.
• Quality and focus oriented.
• Computer/IT systems literacy
• Experience and knowledge of safety and RMP processes
• Good communication, interpersonal, negotiation skills, organizational skills
• Ability to work in cross-functional teams and influence in a matrix organization
• Results driven, committed and accountable

Languages :

• Fluent in both written and spoken English
• Knowledge of other languages desirable (French)