The new colleague will be responsible 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). He/she will be responsible for the Pharmacovigilance (PV) tasks and PV compliance of the respective Patient Oriented Program (POP) supported.
Responsibilities of the job:
- Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, Patient Orient-ed 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.
- 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.
- 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 Research Organization (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible from the trial
- Provide PV support to the POP Owner or other Novartis staff (e.g. POP Champion, ERC, Legal) when contracting with an External Service Provider (ESP)/Healthcare Professional or (HCP);
- Provide POP Adverse Event (AE) training and annual re-training to ESP/HCP/Novartis staff, and document and archive training documentation as required;
- Provide information on the use of Novartis Pharmacovigilance Intake tool (PVI);
- Local PVR: provide local AE reporting and other forms, and country specific information on the focus products associated with the POP (approved doses/dosage forms/indication, etc), if applicable, to ESP/HCP/POP Owner;
- PVR Initiating Country (if applicable): review supporting documents and materials and approve program classification data in POPsys;
- Local or Global PVR: Review and approve program initiation in POPsys.
- PVR for Initiating Country, track and perform Adverse Event Reconciliation (AER) including at program closure in line with SOP timelines and enter the results into POPsys;
- Interact with the POP Owner and POP Champion in order to discuss POP ESP performance and compliance and collaborate with them to; actively follow-up on cases of non-compliance including late AE reporting and ensure appropriate action and risk mitigation (deviations and CAPAs);
- Ensure proper handover of activities when leaving the role/organization/planned leaves and liaise with POP Champion as required
- In collaboration with the POP Owner, responsible for providing guidance regarding source documents and required sample size for Source Data Verification (SDV) to the External Service Provider (ESP)/Healthcare Professional (HCP)/Novartis site conducting the POP.
Education: Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience.
Languages: Romanian is mandatory, as well as fluency in both written and spoken English.
•Knowledge of national and international regulations for pharmacovigilance
•Knowledge of pharmacological and medical terminology.
•Excellent communications, interpersonal and negotiation skills
•Quality and focus oriented
•Additional educational requirements as may be mandated by national requirements.