Vigilance Process Manager
hace 2 meses
392951BR
**Vigilance Process Manager**:
Spain
**About the role**
**Location**: Barcelona, Spain (Hybrid)
In this global role as Vigilance Process Manager, you will be responsible for the end-to-end management of assigned pharmaco
- and devices vigilance processes across Novartis and leadership of cross-functional and mono-functional projects to ensure compliance to global regulatory requirements with maximum efficiency.
**Your responsibilities will include, but are not limited to**:
- Driving continuous process improvement and assessing opportunities for streamlining and automation.
- Leading and/or supporting transformational initiatives, including IT projects/systems and process enhancements, in alignment with the company and department strategy.
- Leading the review of emerging worldwide regulations, performing impact assessments, and driving process changes required to ensure ongoing compliance to global regulatory requirements.
- Authoring and maintaining the assigned processes and the associated procedural documents.
- Mentoring and training new starters and associates from other Global Line Functions and developing and maintaining training material and communications for Novartis and third-party associates.
- Collaborating with other functions to monitor regulatory compliance as well as compliance to internal requirements, measuring effectiveness and implementing mitigation strategies when required.
- Acting as Subject Matter Expert / consultant to other global and local functions on regulatory requirements and assigned business processes.
- Leading and/or supporting as business representative during mergers, spin-offs and acquisitions.
**Commitment to Diversity & Inclusion**:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Role Requirements**
**Essential Requirements**:
- Fluent English (Both Spoken & Written)
- PhD, PharmD, MSc degree or Life sciences degree or equivalent
- Significant medical device experience (Preferably but not necessarily on device vigilance / post-market surveillance) and/or
- Significant Pharmacovigilance experience beyond operational tasks, a demonstrated track of working at process/system-level
- Experience of leading process improvement initiatives.
- Experience in project management and demonstrated ability to lead work groups in a matrix environment.
- Strong analytical and organizational skills and ability to work autonomously
- Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions
**Desirable Skills**:
- Additional languages
**Division**
Development
**Business Unit**
Patient Safety & Pharmacovigilance
**Work Location**
Barcelona Gran Vía
**Company/Legal Entity**
Novartis Farmacéutica, S.A.
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
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