The new colleague will 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).
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 Oriented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
2.Act as Deputy Qualified Person for Pharmacovigilance in Novartis Country Organisation and manage reporting / submission / distribution of safety reports / updates / information (e.
g. SAE, SR, IN, SUSAR, PSUR, DSUR, changes in risk benefit) to Local Health Authorities (LHA) according to regulatory requirements.
3.Manage reporting / submission / distribution of safety reports / updates / information (e.g. SAE, SR, IN / SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities and / or clinical operations in cooperation with other Country Organization Departments.
4.Work with other local / global Patient Safety associates to ensure accurate evaluation of safety data.
5.Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable.
6.Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.
7.Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
8.Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
9.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.
10.Management and maintenance of all relevant Patient Safety databases.
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.Risk Management Plans : Proactively cooperate and collaborate with the RMP key stakeholders on the implementation of Risk Management Plans commitments from PS perspective :
Ensures training of country staff (incl. Sales / Marketing staff, 3rd party etc.) involved in the implementation of the RMPs on general RMP principles.
Ensures training of country staff (incl. Sales / Marketing staff, 3rd party etc.) on RMP Product Key Safety Messages contained in the Educational material (if applicable).
Note : the RMP KSM training delivery can be delegated as appropriate to another function (to be reflected in local SOPs and applicable JDs)
Supports all country departments (as applicable) such as CMO & Patient Safety, Medical, GDO / GMO, Sales / Marketing, HE&OR (Health Economics and Outcome Research), to ensure alignment of all local functions in support of RMP commitment implementation.
Oversee local implementation of RMP Educational material by applicable line function
Ensure that a local process is in place to archive RMP related documents, demonstrating execution of commitments
Drafting & maintaining of local country RMP specific annexes required by regulatory authorities (if required).
Assuming role as site owner (SO)
Coordination of local implementation of RMP commitments
Monitoring of local compliance with RMP requirements
Creation of local RMP commitments for local RMPs (if applicable)
Ensures delegated task owners (TO) are trained in COSTA
Specific local RMP needs as required by local Health Authorities
Sharing best local implementation practices, processes and systems / tools
Education (minimum / desirable) : Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist).
Experience / Professional requirement :