Patient Safety Specialist & RMP Manager

Job Description

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).

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 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.
• 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.
• 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.
• 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.
• 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
• Risk Management Plans Proactively cooperate and collaborate with the RMP key stakeholders on the implementation of Risk Management Plans commitments from PS perspective
• Drives local implementation of RMP commitments for all Novartis Phar-ma/Sandoz/Alcon products
  

 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).

• Manage/oversee country RMP commitment status tracking activities in COSTA (Commitment Status Tracking Application), including
  

 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

• Provides input as required by Global RMP Office, Novartis Patient Safety Management and QPPV on implementation status of local RMP commitments
• As member of the Global/Regional RMP Network, provides input to global RMP Office and countries on
  

 Specific local RMP needs as required by local Health Authorities
 Sharing best “local” implementation practices, processes and systems/tools

Minimum Requirements

Education (minimum/desirable) Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist).

• Fluent in both written and spoken English;
• Fluent in both written and spoken local language.
  

Experience/Professional requirement

• 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
  

Division
Global Drug Development
Business Unit
CMO & PATIENT SAFETY GDD
Country
Romania
Work Location
Bucharest

Company/Legal Entity

NOV PHA SERVICES ROU
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular