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
1.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.
2.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.
3.Work with other local / global Patient Safety associates to ensure accurate evaluation of safety data.
4.Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable.
5.Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.
6.Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
7.Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
8.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.
9.Management and maintenance of all relevant Patient Safety databases.
10.Ensure that relevant local literature articles are screened as appropriate.
11.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.
12.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.
13.Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
14.Ensure training and oversight of staff, as applicable.
15.Manage and maintain efficient Patient Safety filing and archive system.
16.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
17.Act as Nigeria QPPV
18.And other agreed tasks assigned by manager
Diversity & Inclusion / EEO
Education (minimum / desirable) :
Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience
Experience / Professional requirement :