KEY RESPONSIBILITIES
- Drive continuous process optimization and simplification by alignment of relevant stakeholders globally and locally and assessing opportunities for streamlining and automation.
- Lead/support as Senior subject matter expert (SME) assigned complex cross functional and PS&PV projects, including IT projects/systems, which are of a high priority / criticality to the business.
- Collaborate closely with the product owner and product team, to ensure that the product meets the required standards and is fit for its intended purpose. This involves providing expertise in process management, identifying, and mitigating risks, ensuring compliance with relevant regulations, and facilitating continuous improvement.
- Act as process owner for one or more assigned high complexity/ high impact vigilance process within their functional area:
- Lead active surveillance and analysis of emerging regulations, perform impact assessments and drive process changes required to ensure ongoing compliance to global regulatory requirements.
- Analyze the impact of other Novartis processes and organizational changes on assigned processes.
- Lead the development, communication strategies and maintenance of respective procedural documents and training materials.
- Collaborate with other functions to establish requirements for metrics trend analyses, generate knowledge and mitigate any identified risks.
- Act as SME / consultant to PS&PV associates, Country Organizations and other Global Line Functions on regulatory requirements and assigned business processes.
- Own and maintain relevant Pharmacovigilance System Master File (PSMF) sections and annexes.
- Maintain the content of Business Continuity Plans for all respective processes, including IT applications for Key Business Processes.
- Assume the role of end-to-end process owner when assigned.
- Act as a subject matter expert during audits and inspections of the vigilance system (e.g., EMA, FDA) and lead preparation of responses to findings and the development and implementation of corrective and preventative actions in alignment with the company strategy.
- Lead collaboration with other Global Line Functions across Novartis and Third Parties to establish and meet joint accountabilities.
- Lead and/or act as business representative during mergers and acquisitions.
ESSENTIAL REQUIREMENTS
- PhD, PharmD, MSc degree or Life sciences degree or equivalent
- Fluency in English. Knowledge of other languages desirable.
- Minimum 6-8 years of experience in the pharmaceutical industry, particularly pharmacovigilance.
- Leadership and (matrix) management experience.
- Ability to lead global and cross-functional work groups and deliver cross-functional initiatives in a matrix environment, deal and interact with a wide variety of people at all levels.
- Strong organizational, analytical and project management skills.
- Strong negotiation and communication skills and ability to operate effectively in an international, matrix environment
- Quality focus
Salary
Competitive
Monthly based
Location
Barcelona, Catalonia, Spain
Job Overview
Location
Barcelona, Catalonia, Spain
