Patient Safety Specialist

Patient Safety Specialist
Job Purpose

To support management of Patient Safety operational processes at Country Organization in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Novartis group marketed and investigational products (drugs and devices).

Key Responsibilities

• Manage collection, processing, documentation, reporting & follow-up of all adverse event (AE) reports for all Novartis products from clinical trials, non-interventional studies, Patient Oriented programmes, literature, Spontaneous Reports, etc.
• Manage reporting/submission/distribution of safety reports/updates/info to Local Health Authorities (LHA) and/or clinical ops in cooperation with Country Organization (CO) departments.
• Work with local/global Patient Safety (PS) associates to ensure accurate evaluation of safety data.
• Interact & exchange relevant safety info with LHA, PS associates, functional groups & 3rd party contractor.
• Survey & monitor national PV regulations & provide update to global PS organization.
• Develop, update & implement local procedures to ensure compliance with PS global procedures & national requirements.
• Input, review & approval of program proposals for language, content & establishment of necessary controls on collection & reporting of AE info
• Perform reconciliation with departments for potential AEs resulting from medical inquiries, quality related complaints & other sources.
• Mgmt & maintenance of all PS databases.
• Prepare & submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development & implementation of corrective action(s).
• Develop & update training materials for PV & ensure training of CO associates on relevant PS procedures for AE reporting, including field force & 3rd party contractor.
• Ensure support for & close-out of audits, corrective action plan, investigation & HA inspections.
• Manage & maintain efficient PS filing & archive system.
• Liaises with Local RA to ensure tracking of status of RMP commitments implemented locally.

• Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist).
• 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 savvy.

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas.

In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 125,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world.

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Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Global Drug Development
Research & Development
Full Time