CSL Vifor, a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company are experiencing rapid growth due to pipeline realization, optimization and global partnership alliances. At this time we are looking to appoint an interim UK Medical Information and Safety Manager who may also act as the UK National Contact Person to be based at our offices in in Staines with the potential for flexible home / office based working.
This will be for a period of 12 month. You will lead a small medical information team focused on delivering compliant Medical Information (MI) and Pharmacovigilance (PV) responses for the UK and Republic of Ireland, to patients, healthcare professionals, relevant health authorities and colleagues. In addition, you will lead MI and PV activities related to training, medical compliance, audit and inspection readiness. You will be a seasoned MI and Safety Manager with experience gained in a similar role within the UK pharmaceutical and/or biotechnology industry.
Key Measures of Success
· Quality, consistency and effective management of Medical Information and Pharmacovigilance systems and enquiries.
o Effective management of MI and PV processes internally and externally
o No major findings from audits or inspections
· Maintenance of up to date product labels and related materials
· Maintenance of Frequently Asked Questions (and their answers) and Key Information Documents (KIDS).
· Upkeep of key information sources such as databases, factsheets and other technical information.
· Effective engagement and feedback with other Departmental functions.
· Maintenance of excellent results from external and internal quality audits.
· Maintenance with the Medical Director of a fully staffed and operational MI and PV Team
- Provide leadership and guidance to the MI team and the broader organisation for the delivery of MI and PV systems with acceptable quality and compliance
- Mentoring and development of other Departmental members
- May act as the UK National Contact Person (NCP) for PV; reporting to UK QPPV and single point of contact for the UK and Republic of Ireland National Health Authorities concerning safety issues for Vifor Pharma products and responsible for:
- Local Drug Safety Responsible ensuring oversight and compliance of PV activities across the UK and Ireland
- Update and maintenance of UK PV System Master File (PSMF) documents
- PV related CAPAs and Deviations
- Provides up-to-date, balanced and relevant medical, technical and pharmaceutical information on Vifor Pharma products to both external and internal customers in accordance with the ABPI Code of Practice.
- Develops an in depth knowledge on Vifor Pharma products, providing expertise and advice to others within the UK organisation.
- Supports the collection, documentation and communication of all pharmacovigilance reports and information.
- Delivers company training; for example, but not exclusively, on Medical Information and Pharmacovigilance activities.
- Supports and logs the collection, documentation, communication and information relating to product and service complaints.
- Involvement in the company’s preparation and management of internal and external audits and inspections.
- Provides expertise that support the organisation with material review, copy approval and scientific assessment
- Maintains local regulatory documents and provides oversight of regulatory activities
· Demonstrates strong communication skills with an ability to efficiently and effectively communicate orally and in writing.
· Outstanding analytical skills – science-based and patient oriented
· Broad scientific and medical knowledge, with demonstrated ability to expand their learning
· Strong Medical Communications skills (study evaluation and interpretation, medical writing, presentation development, training skills, usage of medical / scientific databases, usage of online tools).
· Works and champions ideas at a National level and demonstrates an ability to apply entrepreneurial thinking and spirit in their working practice.
· Strong customer orientation with the ability to continuously expand market knowledge.
· Organisational excellence, with a relentless pursuit of quality.
· Displays strong organisational and time management skills; reliable in completing tasks and delivering on commitments in a timely manner.
· Builds effective relationships with a variety of external and internal customers – acts as a cross functional leader when required.
· Acts as a role model for others in line with CSL Vifor values.
· Ability to mentor others
- Degree in pharmacy or life science.
- 2-4 years’ experience in the pharmaceutical industry within a MI or PV role (or equivalent experience)
- Ability to communicate information clearly and logically, both orally and in written form
- Ability to assimilate and interpret scientific and other relevant information.
- Demonstrated ability to prioritise their own workload and where necessary, that of their Teams workload.
- Sound knowledge and understanding of the ABPI/IPHA Code of Practice.
- Demonstrates high standards and attention to detail in their day to day work.
- Sound knowledge of UK, Irish and EU pharmacovigilance legislation and the regulatory environment
- Previous line management experience within PV or Safety team at the global or affiliate level
- Experience of working in a customer focused environment.
- Experience of mentoring