Band

Level 4

Job Description Summary

To lead Patient Safety operational processes at the Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for vigilance of Novartis group approved, marketed and investigational products (incl. drugs, food supplements and medical devices).

Job Description

Key responsibilities:

• Manage a team of PS Associates (such as PS Specialists, PS Senior Specialists and/or PS Managers) in line with the country PS organizational structure and PS strategy in place.
• Act as qualified delegate of the Local Qualified Person for Pharmacovigilance/ Local PV Responsible Person in Novartis Country Organization, as defined by local regulation and applicable legislation, in terms of ensuring compliance of adverse drug reactions monitoring and submission.
• Act as qualified delegate of the Country Patient Safety Head in terms of operational vigilance processes.
• Ensure robust oversight and compliance in terms of reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN, SUSAR, PSUR, DSUR, changes in risk-benefit profile) to Local Health Authorities (LHA) according to regulatory requirements and Novartis procedures.
• Work in close collaboration with other local and global medical safety functions to ensure accurate evaluation of safety data.
• Interact and exchange relevant safety information with Health Authorities, other functional groups, third-party contractors, and PS associates, as applicable.
• Monitor national pharmacovigilance regulations and provide update to global PS organization.
• Set up, update, and implement local procedures to ensure compliance with PS global procedures and national requirements.
• Ensure local PS-related RMP commitments are executed and properly documented
• Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract.
• Act as a key partner who provides input, during the process of establishing local programs (ex. POPs, DEAs; SM/SML, etc.): comments on proposals for vigilance language, content, and establishment of necessary controls on collection and reporting of adverse event information.
• Ensure that relevant local literature articles are screened, as appropriate.
• Supervision of management and maintenance of all relevant PS databases.
• Ensure timely preparation and submission of KPI reports on AE reporting and AE follow-up attempts including identification of root cause(s) e.g., for late reporting to HA, missed or delayed follow-up attempt, development and implementation of corrective and preventative action(s) as needed.
• Support in developing and updating training materials for pharmacovigilance and ensure training of Country Organization associates on relevant PS 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 selection, and recruitment of qualified PS team members and their further professional development.
• Ensure training and oversight of commissioned staff, as applicable.
• Contribute to the preparation and update of the local Pharmacovigilance System Master File as per regulation and related procedures.
• Other agreed tasks assigned by manager.

Essential requirements:

• Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience
• Fluent in both written and spoken English
• Fluent in both written and spoken local language
• Knowledge of other languages (desirable)
• Leadership and (people-)management skills
• Excellent communications and negotiation (networking) skills
• Quality and results oriented
• Business mindset
• Computer skills
• 3 years’ experience in pharmacovigilance or equivalent field

Skills Desired

Databasing, Employee Training, Management Reporting, Pharmacovigilance, Safety Science, Waterfall Model