Vigilance Process Manager

hace 6 meses

Barcelona, España Novartis A tiempo completo

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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