• Basel

Site 1201 F. Hoffmann-La Roche AG

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von: 1201 F. Hoffmann-La Roche AG | Ort: Basel | Referenz: c895fc3c-68fb-4378-8ba0-f95c392259b6

The Position

The IPV Business Process Leader with a focus on Digital Health and Media leads and drives implementation of drug safety data acquisition for Digital Health and Digital Media Channels. The IPV BPL leads and drives PV excellence across Roche Affiliates through the application of best-in-class global PV standards, quality, compliance and inspection readiness. This is in line with PV policies, best practices, processes and other resources. Over the entire process lifecycle, the IPV BPL leads and/or contributes to process development, Affiliate Patient Safety (APS) process implementation, and continuous improvement in collaboration and partnership with IPV Community Heads and Patient Safety Country Cluster Leads (PS CCLs).

Main Responsibilities:

  • Acts as Business Process Owner owner representing the affiliate safety aspects and needs for the dedicated process

  • Is a member of the process network and collaborates with global process owners to influence global PV processes impacting Affiliates

  • Subject matter expert for the safety aspects in Digital Health and Media

  • Stays up to date with current and future health technology advancements combined with the challenges of AE detection and extraction from Digital Health and Media systems

  • Supports the design and role-out of process related systems-

    • Identify and assess impact on all stakeholders, processes and tools and manage associated communications accordingly

    • Drive and foster improvement and implementation projects (e.g. synchronization with Affiliate PV Manual chapters, preparation of metrics, etc.)

    • Serve as a point of contact, moderator and coach between Affiliate and Headquarter for PV relevant communications

    • Escalate issues impacting global PV process

What do you bring?

Scientific qualification (PhD or MSc) in healthcare profession or relevant life science or nature science discipline, or equivalent professional experience

Knowledge and interest in the digital landscape of commonly used Digital Health projects offered by the Pharmaceutical industry.

Further qualification/certification in project management methodologies and/or change management,

Experience, Skills, Knowledge:

  • Significant experience in PV, clinical research, development, drug safety science or related experience

  • Experience in Affiliate PV roles or a global role focusing on Affiliate support

  • Proven interest and knowledge of Digital Health Systems and common Social Media usage by the Pharmaceutical Industry for Health topics and purposes

  • Broad understanding of global and Affiliate PV processes, including safety Affiliate roles. Additional experience in regional and/or headquarter roles is desirable – specifically PV operational knowledge and knowledge of risk management

  • Past experience working with health authorities

  • Experience in process design and process-level oversight (in particular for the processes mentioned as primary focus)

  • Demonstrated experience of proactively driving a team in a variety tasks, projects and team management

  • 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, effectively lead and facilitate project team meetings (when acting as project leader)

  • Past experience as Business Process Owner is of advantage

  • Strong interpersonal skills: proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams

  • Good influencing and negotiation skills: proven abilities to influence others without authority

  • Good communication (including the communication via the Roche social media publishing) and presentation skills

  • Proven professional maturity, confidence and competence and advanced influencer skills

  • Pride in summarizing and communicating the key points and business case for others to effectively and expeditiously make important decisions

  • Embraces diversity and inclusion

  • Good knowledge knowledge of the google enterprise software applications, excellent Word, Excel and PowerPoint skills, skill in using and understanding of the social media platforms

Travel Requirements: Willing to travel internationally

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

 
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