International PV Business Process Leader (m/f/d)

REFERENCE NUMBER:

673591/1

MY DUTIES:

- The IPV BPL acts as Business Process Owner for PV affiliate-relevant global PV processes, and is responsible to involve an appropriate set of affiliates in global PV process design, development and maintenance
- Provide content contributions to PV process-related affiliate communication and training needs
- Collaborate 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
- Contribute to collection and evaluation of affiliate feedback (eg after process roll-out), and reintegrate for future process improvements
- 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

MY QUALIFICATIONS:

- Min. Scientific qualification (PhD or MSc) in healthcare profession or relevant life science or nature science discipline, or equivalent professional experience
- PV, clinical research, development, drug safety, quality science or related experience
- Experience 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
-Excellent Word, Excel and PowerPoint skills, knowledge of the gSuite enterprise software applications is a plus

MY BENEFITS:

- A very renowned company
- You will work in an international environment

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

MY CONTACT AT HAYS:

My contact person
Konstantina Glykou

Reference number
673591/1

Contact
E-Mail: [email protected]