Novartis Patient Safety Specialist at Novartis Nigeria

Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines

We are recruiting to fill the position below:

Job Title: Novartis Patient Safety Specialist

Job ID: 345355BR
Location: Lagos
Job type: Full time
Employment Type: Regular
Business Unit: Global Health PH
Division: Pharma
Functional Area: Research & Development
Early Talent: Yes

Job Description

• 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).

Roles and Responsibilities

• Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, Patient Ori-ented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with empha-sis 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 Re-search Organization (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible from the trial
• Act as Nigeria QPPV
• And other agreed tasks assigned by manager.

Commitment to Diversity & Inclusion:

• Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements
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 Requirements:

• 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.

Application Closing Date
Not Specified.

How to Apply
Interested and qualified candidates should:
Click here to apply online