Vigilance Standards and Collaborations Specialist

Vigilance Standards und Collaborations Specialist

Location

Cambridge (UK)

Start Date

As Soon As Possible

Main tasks

Provide project Management to facilitate production of aggregate reports

  • Provide leadership and structure around aggregate reports to ensure final delivery of the document meeting all expectations.
  • Plan and organise succinct, relevant KoM with clear post-meeting minutes.
  • Data request management.
  • Author the non-medical sections of the document.
  • Co-ordinate appropriate review and approval of the document in Athena.
  • Evaluate comments from reviewers of final draft document for appropriateness and respond accordingly.
  • Assembly of final document.

Facilitate the development and maintenance of VRM and worldwide processes, SOPs and systems

  • Manage the Safety Surveillance System and associated reports.
  • Train new starters on the VRM SOPs, processes and Systems.
  • Development and maintenance of VRM templates (aggregate reports, responses to queries).
  • Oversight of SOPs within VRM.


Provide project management support for VRM projects

  • Provide input and maintain the VRM responsible sections of the PSMF.
  • Facilitate the VRM and SEG meeting providing quality documentation (agendas and minutes) in a timely manner.
  • As VRM representative, provide pre- and post-inspection support and attend internal and external inspections when required. Implement corrective and preventative actions within VRM, if required.
  • Project manage the VRM aspects of Response to Queries.
  • Provide input into VRM budgets and timelines.
  • Project manage the development, maintenance and distribution of the VRM reports schedule. Ensure correct input from Product experts into the schedule.
  • Develop a tracking tool to track all RMPs risks and maintain oversight.
  • Calculate patient exposure sales data, as required.
  • Track VRM deliverables.
  • Lead process excellence projects within VRM.


External Purdue/Mundipharma/NAPP projects

  • Project Manage the development, maintenance and distribution of the Global Reports Schedule.
  • Interact with other Drug Safety Centers to ensure consistency in worldwide safety processes.
  • Work with Drug Safety Systems in the development and maintenance of VRM COGNOS reports.


Other

  • Attend and participate in appropriate learning events for both personal and professional development.
  • Undertake any other reasonable tasks as required.

Key Competencies

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Main requirements

Qualifications & Experience

  • Project management experience essential or experience in managing complex projects.
  • University degree in pharmacy, medicine or biology or comparable training.
  • Experience in the Pharmaceutical industry is essential.
  • Some medical / pharmacological knowledge in the medical areas / of the medicinal products relevant to Mundipharma would be beneficial.
  • Fluency in spoken and written English.
  • Excellent IT skills in Microsoft PowerPoint, Excel and Word and some knowledge of electronic databases.
  • Global Safety-Regulatory knowledge of applicable pharmacovigilance regulatory requirements.
  • Project management training (Prince 2 equivalent)

 Personal & Leadership Characteristics

  • Proven excellent communication skills at all levels in the organization and evidence of ability to work in cross functional teams. Communication must be credible, articulate and authoritative.
  • Outstanding commitment, great sense of responsibility and reliability and an ability to work and (re)prioritise under pressure, with self organisation skills and confidence.
  • Strong accurate and methodical approach to work, with quality orientation/attention to detail but must be able to be pragmatic when required.
  • Open-minded, forward thinking and confident in embracing and leading change
  • Ability to work both independently and as part of a team
  • Recognises the need for and seeks assistance from appropriate internal and external resources for projects with ability to recommend or clarify requirements/solutions.
  • Strong delivery focus – able to deliver against timelines and achieve results taking personal accountability for decisions and delivery of results.
  • Consistently demonstrates and encourages others to demonstrate the Company’s Core Values; Honesty, Respect, Passion, Innovation, and Commitment.
  • Strong ethical standards and a high level of personal integrity.
  • Adheres to the Company’s Compliance and Code of Business Ethics guidelines.

Contact Information

Name: Sophie Anthony
Email: MR.HR@mundipharma-rd.eu
Telephone: 01223 400400
Adress: Mundipharma Research Limited
Unit 196
Cambridge Science Park
Milton Road
CB4 0GW

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