Job Description Summary You will be responsible for the end-to-end management of assigned pharmacovigilance and devices vigilance processes across Novartis and leadership of PS&PV projects to ensure compliance with global regulatory requirements with maximum efficiency.
Job Description Major Activities Drive continuous process improvement by alignment of relevant stakeholders globally and locally, assessing opportunities for streamlining and automation.
Lead assigned PS&PV projects and support higher complexity/criticality projects led by (Senior) Vigilance Process Managers, including IT projects/systems, in alignment with the company and department strategy.
Act as process owner / deputy process owner for assigned vigilance processes: Support active surveillance and analysis of emerging regulations, perform impact assessments, and drive process changes to ensure ongoing compliance with global regulatory requirements.
Author and maintain the assigned processes and the associated procedural documents.
Mentor and train new starters in PS&PV and participate in the creation and maintenance of training material and communications for Novartis and third-party associates.
Act as Subject Matter Expert / consultant to PS&PV associates, Country Organizations, and other Global Line Functions on regulatory requirements and assigned business processes.
Own and maintain relevant PSMF sections and annexes.
Maintain the content of Business Continuity Plans for all respective processes, including IT applications for Key Business Processes.
Role Requirements PhD, PharmD, MSc degree or Life sciences degree or equivalent.
Minimum 2-4 years of experience in the pharmaceutical industry, particularly pharmacovigilance.
Experience in medical device vigilance is desirable.
Skills Experience of leading working groups.
Procedural document writing experience.
Good analytical skills / proven ability to work with data.
Strong presentation and communication skills, and the ability to operate effectively in an international environment and across functions.
Strong organizational skills.
Ability to mentor and coach.
Quality focus.
Languages Fluency in English.
Knowledge of other languages is desirable.
Skills Desired Databases Employee Training Filing Documents Pharmacovigilance Reporting Safety Science #J-18808-Ljbffr