Vigilance Standards and Collaborations Specialist - United Kingdom
As Soon As Possible
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.
- Attend and participate in appropriate learning events for both personal and professional development.
- Undertake any other reasonable tasks as required.
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.
|Adress:||Mundipharma Research Limited |
Cambridge Science Park