09 Feb

Compliance Manager Jobs Vacancy at Actelion London

Position
Compliance Manager
Company
Actelion
Location
London ENG
Opening
09 Feb, 2018 30+ days ago

Actelion London urgently required following position for Compliance Manager. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Compliance Manager Jobs Vacancy at Actelion London Jobs Details:

Compliance Manager - (1800002K) ABPI /IPHA Code of Practice Compliance

  • Act as affiliate Compliance Champion and be point of contact for Code compliance champions from other affiliates
  • Provide detailed review of promotional and non-promotional materials / activities to ensure scientific and technical accuracy, and compliance with ABPI Code of Practice
  • Develop and maintain scientific expertise on company’s products and therapy areas
  • Develop and maintain repository of up-to-date PIs for Actelion products
  • Develop and maintain all ABPI Code-related SOPs in collaboration with relevant internal stakeholders
  • Manage the Transfer of Value and disclosure process for UK HCPs and HCOs, including training, data capture and upload onto relevant external platforms
  • Develop and implement ABPI compliance training for internal teams (medical, sales, marketing) and lead/organise training and sharing of best practice for new and existing signatories
  • Champion general awareness of ABPI compliance within UK company and with other affiliates
  • Represent UK on global compliance network
  • Manage the Code of Practice complaints process in relation to inter-company disputes and PMCPA / MHRA complaints, including the strategic direction, content and process involving appropriate stakeholders to achieve best possible outcome
  • Respond to Med Info enquiries from internal and external stakeholders
  • Act as Zinc champion and system owner, including system maintenance/development and metrics
  • Responsible for the monitoring of the company website to ensure data is accurate and up to date
  • Responsible for updating local systems as applicable following labeling changes to the SmPC and PIL, i.e. eMC, iComply, Mims, BNF etc.
  • Medical Information
  • Respond to all medical information queries from both internal and external stakeholders with the most up-to-date information
  • Liaise with Global Medical Information Team in creating and regularly updating standard reply letters
  • Ensure that all medical information queries are managed through MedIS.
  • Keep up-to-date with medical information processes through self-directed learning, attendance at relevant meetings and ensure that Actelion UK & ROI is up to date with relevant legislation
  • Pharmacovigilance
  • Act as Actelion UK Affiliate Safety Officer
  • Maintain strong working knowledge of local regulatory requirements relevant to

pharmacovigilance as well as worldwide requirements

  • Ensure reporting and handling of adverse events according to the relevant SOPs
  • Provide Induction and annual PV training
  • Maintain a close working relationship with Global Drug Safety (GDS) and EU QPPV and keep them up-to-date on new local regulations/requirements
  • Ensure that clear, documented, contractual arrangements are in place between Actelion UK and its third parties
  • Ensure PV contractual agreements in place where appropriate
  • Supports the affiliate and the Global Organisation during Regulatory audits from the Competent Authorities
  • Other
Essential
  • UK registered pharmacist (preferred)/Life science background
  • 3+ years' experience of working in the UK pharmaceutical industry
  • Excellent experience of medical information processes, the ABPI and IPHA Code of Practice, MHRA Blue Book and other relevant regulations
  • Desirable
  • Experience of working within the respiratory and/or cardiology therapeutic areas
  • Final Signatory experience to PMCPA standards
  • Communicating with relevant Global Head Office teams to ensure smooth flow of medical information
  • Reporting of adverse events at the affiliate level
  • Technical Skills and Behaviors
  • Ability to understand and interpret complex scientific concepts and communicate findings to customers
  • A proven ability to work effectively as part of a multi-functional team
  • Excellent organizational and problem-solving skills with the ability to work under pressure and meet tight deadlines
  • Excellent written and verbal communication skills including the ability to make and deliver engaging presentations
  • Strong attention to detail

Primary Location : UK-ENG-London Job : Regulatory Affairs Schedule : Full-time Job Type : Standard Job Posting : Feb 9, 2018


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