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International PV Business Process Leader (M/F/D)

International PV Business Process Leader (M/F/D)

Chemie / Pharma / Biotechnologie
  • Temporär - Vollzeit
  • Referenz : INT-039551
  • Teilen:

Einzelheiten

  • Region Basel
  • Art des Vertrags Temporär - Vollzeit
  • Tätigkeitssektor Chemie / Pharma / Biotechnologie

Einführung

As a preferred supplier for Roche Basel we are looking for an individual as

International PV Business Process Leader (M/F/D)

(contract for 12 months contract, with possible extension). The earliest start date is within 3 months. Home Office possible, onsite work at least once per week.

Aufgabenbeschreibung

  • 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,
  • 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
  • Excellent Word, Excel and PowerPoint skills, knowledge of the gSuite enterprise software applications is a plus
  • 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: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application. Please upload your CV in English along with your degree certificate and latest reference letter.

Informationen

  • Agentur GLOBAL RECRUITMENT - +41 44 266 50 25
  • Veröffentlicht am 2. Februar 2023
  • Berater-in Claudia Zah