International Pv Business Process Leader

**EINFÜHRUNG**:
As a preferred supplier for Roche Basel, we are looking for an individual as

**International PV Business Process Leader**:

- (contract for 6-12 months, with possible extension). The earliest start date is within 3 months.

**AUFGABENBESCHREIBUNG**:
The IPV BPL acts as Business Process Owner for PV affiliate-relevant global PV processes, and is responsible to:

- to involve an appropriate set of affiliates in global PV process design, development and maintenance
- to provide content contributions to PV process-related affiliate communication and training needs
- The IPV BPL collaborates with CCLs, Affiliates and global functions (eg Safety Risk Management, Quality, Medical Affairs, Regulatory Affairs, Clinical Operations etc.) to achieve high-quality and compliant affiliate execution of the global PV processes.
- work closely with the respective Global Process Owners and other Business Process Owners ensuring ultimately end-to-end process oversight and is responsible for ensuring effectiveness of global Pharmacovigilance (PV) processes that impact PV Affiliates,
- to contribute to collection and evaluation of affiliate feedback (eg after process roll-out), and reintegrate for future process improvements,

The IPV Business Process Leader shall:

- Drive the continuous evaluation and refinement of global Affiliate PV processes and corresponding systems/tools to ensure quality and compliance with regulations and guidelines.
- Collaborate with global process owners to influence global PV processes impacting Affiliate
- Design, influence and review PV relevant metrics and other relevant data to support global and regional oversight, supporting the data capture in the adequate platforms for local and regional reports
- ensure adequate input from an appropriate set of Affiliate staff during the design phase of global processes and ensure the process communication and training meets the Affiliate needs
- Detects and escalates issues impacting global PV processes or potentially impacting multiple Affiliates as appropriate
- Lead and/or contribute to PV improvement efforts, PV initiatives and projects in close collaboration with IPV Community Heads, CCLs and global process owners:

- Identify and assess impact on all stakeholders, processes and tools and manage associated communications accordingly
- Effectively lead and facilitate project team meetings (when acting as project leader)
- Support affiliate implementation and change management
- Establishes best practices across Affiliates compliance
- Escalate issues impacting global PV processes
- Serve as a point of contact for between Affiliate and Headquarter for PV relevant communications
- Collaborate in the continuous improvement activities for the IPV Business Process Management team

**ERFORDERLICHES PROFIL**:

- Min. Scientific qualification (PhD or MSc) in healthcare profession or relevant life science or nature science discipline, or equivalent professional experience
- Min. 8 or more years PV, clinical research, development, drug safety, quality science or related experience
- Min. 3 years minimum in Affiliate PV roles or a global role focusing on Affiliate support
- Broad understanding of global and Affiliate PV processes, including safety Affiliate roles
- Experience in process design and process-level oversight (in particular for the processes mentioned as primary focus)
- In-depth knowledge of PV, GVP, ICH-GCP and other relevant standards and guidelines
- Well-versed in medical and safety aspects of FDA, EMEA, NICE and other relevant regulations
- Good project and process management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such

**Competencies /soft skills**:

- Ownership and accountability
- Decision making
- Strong communication, influencing and negotiation skills. Strong interpersonal skills and partnering skills. Able to work efficiently and effectively in cross functional and matrix teams

**Nice to Have**:

- Further qualification/certification in project management methodologies and/or change management.
- Additional experience in regional and/or headquarter roles is desirable - specifically PV operational knowledge and knowledge of risk management
- Experience working in project works with health authorities

**Application process**:
Interested? You can find more information here: