SME – Medical Reviewer – UK, US, Europe

Celegence is looking for a Labeling Subject Matter Expert based in the UK or Europe to review Core Company Data Sheets for a large pharmaceutical client.

Roles & Responsibilities

This role includes some of the following activities in the context of Labeling and CCDS :

Medical Review:

  • Review of gap analysis and provide medical justification comments for inclusion or exclusion of deviation
  • Review ADR and identify PTs for line listings
  • Review of line listings cases
  • Performs literature search/review the articles for using them as a supporting evidence for the information in CCDS
  • Author and review the Clinical Overview, Non-Clinical Overview and medical evaluation document
  • Provides general regulatory guidance

Medical Writing (On need basis):

  • Gap analysis and identification of deviation
  • MedDRA coding of adverse drug reaction
  • Literature search and highlighting the relevant text
  • Preparation of literature data sheet
  • Preparation of draft CCDS
  • Health Authority website check for safety changes
  • CCSI package maintenance

General Project / Customer Specific:

  • Undergo training by customer for their specific processes (SOP), systems for data extraction, quality review procedures etc.
  • Understand report template requirements and existing reports for updates as part of the project activities
  • Understand different source documents and reports like company core data sheet, SmPC, US labels, HA assessment reports, previous finalized reports etc.

Planning and Coordination (support role):

  • Responsible for successful planning and organizing by working with Project Manager
  • Setting turnaround time for completion of CCDS and track deliverable progress
  • Ensure the quality of work meets customer expectations as per SLA and KPIs
  • Establish and maintain communication between Project Manager and the client team
  • Maintains an expert, current knowledge of regulations, legislation, best practices and guidelines relating to regulatory (i.e. GxP, Annex 11, 21 CFR Part 11, ISO standards etc.)
  • Understands and will abide by ISMS policy and processes of the company

Education & Experience

Education:

  • Master’s Degree in the relevant field

Experience:

  • Minimum requirement of Master’s degree and experience in pharmacovigilance and labeling activities for pharmaceutical products
  • A candidate with substantial, relevant work experience of 8 or more years is required
  • Good knowledge of ICH and other regulatory requirements that govern the Safety of Medicines in EU, US and the Emerging markets

Skills and Competencies

Skills:

  • At least 10 years of experience in working in a pharmaceutical company demonstrating an awareness of global labeling and PV procedures
  • Experience of working with staff that is both offshore and onshore in a matrix organization
  • Strong background in regulatory requirements as well as understanding of European, US and international regulations related to PV and labeling
  • Experienced in preparing, review and update dossier including CDS (Core Data Sheet), USPI (United States Package Insert) & SmPC (Summary of Product Characteristic) and their associated Patient Labeling Documents
  • Performed compliance review in terms of QRD (Quality review of document), PLR (Physician Labeling Rule), labeling naming convention and other content & formatting related aspects
  • Performed gap analysis by comparing the local labels and RSI in terms of safety profile
  • Perform literature search for the safety sections of CCDS using relevant database
  • Experienced in performing HA website search (EMA, FDA and MHRA) for any new safety signals
  • Experience of working with external pharmaceutical data standards (pharmacopeia, standard terms, ISO, MedDRA, EDQM etc.)
  • Analytical Skills: Able to efficiently determine the root cause of a problem, identify viable, risk-balanced solutions and implement such solutions appropriately

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management
  • Knowledge of PV regulations
  • Scientific knowledge to understand all aspects of regulatory issues

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Leadership Skills
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Please make sure you have the relevant work visa prior to applying

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