Job purpose:

Management and monitoring of Patient-oriented programs (POPs) and coordination of the local implementation of Risk Management Plans (RMPs) as well as management of safety aspects of Digital Engagement Assets (DEAs) and Social Media listening programs (SMLPs) to ensure compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for vigilance of Novartis group marketed and investigational products (drugs and devices)

Responsibilities include but are not limited to:

• Support the Graduated Plan Officer / Patient Safety Responsible (PSR) in the timely and correct implementation of the pharmacovigilance activities defined in the RMP
• Work close together with other local/global Patient Safety associates, RMP managers, global RMP office, Marketing, Medical and Regulatory Affairs to ensure adequate fulfillment of RMP requirements.
• Train and support the POP program owners, ESPs or other involved personnel during the whole program conduction to ensure POPs performance is in line with internal and external requirements.
• Ensure regular quality controls and deviation management during the conduct and after the closure of a POP (reconciliation, source data verification (SDV), integrity and correctness of database records) according to the applicable Novartis standards and vigilance guidelines
• Manage local PV tasks for SMLP/DEAs together with other local/global Patient Safety associates, SMLP and DEA Owners as well as Digital Champions to ensure accurate conduction of programs according to PV requirements
• Provide PV training to SMLP and DEA Owner, ESPs or other personnel involved in the conduction of a SMLP / DEA
• Ensure global Guidelines regarding SMLP/DEA are implemented locally taking special local requirements into account
• Survey and monitor national vigilance regulations and provide update to global Patient Safety organization and other affected global departments
• Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements
• Organize, implement and participate in Novartis SDV, audits and official inspections and ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections
• Play an active role in cross-functional teams on safety matters of special projects and RMP management relating to investigational and marketed drugs and devices