Vigilance Risk Management Placement

by Mundipharma Research

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Job Details

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Deadline: 3rd April 2015
Salary: Competitive
Length: Placement (10 Months+)
Roles: Pharmaceutical, Science
Location: South East
City: Cambridge

About Mundipharma Research

Based on the Cambridge Science Park, we provide world class research services to the Mundipharma/Napp Group of independent associated pharmaceutical companies throughout Europe, Asia Pacific and Latin America. With an international reputation for innovative research, we successfully and continuously improve the lives of our patients by discovering and developing new therapeutic products.

One Year Vigilance Risk Management Student Placement

The Drug Safety and Pharmacovigilance Department (MDSP) undertake all activities relating to the detection, assessment and understanding of adverse drug reactions (side effects) relating to marketed and investigational products. This department is also responsible for the implementation of appropriate measures to minimise drug safety risks for patients.

This placement offers broad opportunities within a varied, exciting and challenging working environment. There will be scope to learn alongside experienced, industry leading professionals, with key responsibilities including providing comprehensive support to the Vigilance Risk Management Team, with a focus on post marketing safety support.

Broad purpose of the job

  • Responsible for supporting the Vigilance Specialists in reviewing and analysing the safety of the Company’s investigational and post-marketing products to ensure consumer, prescriber and regulatory authority confidence.
  • Also responsible for supporting the Vigilance Specialist in preparation of periodic regulatory safety reports, signal detection and evaluation, benefit-risk assessment, risk management plans (incorporating risk minimisation), relevant labelling support and responding to regulatory authority safety queries, for both investigational and post-authorisation products.

Your responsibilities will include:-

  • Support of Safety Surveillance (signal detection; signal evaluation; benefit risk assessment; risk mitigation)
  • Support labelling activities (SmPC /PIL)
  • Support production of Aggregate reports (PSURs, DSURs etc) and Risk Management Plans (RMPs)
  • Providing support and requested information to relevant parties

Specific Duties & Responsibilities

General support for the Systems and Processes Team

  • Responding to emails from within the department, organisation and global Independent Associated Companies requesting support on Medical Systems
  • Arranging and attending meetings with internal/external customers and external providers
  • Preparing reports and documentation for meetings and training sessions
  • Take responsibility for own learning and development in order to reach and maintain the required level of skills, knowledge and experience to perform the role
  • Job shadowing various members of the Drug Safety and Pharmacovigilance Team, to gain an understanding of the full responsibility.
  • Be willing to travel within Europe if requested.
  • To undertake any other duties as may be reasonably requested by other members of Vigilance Risk Management

Support the Vigilance Specialist

  • Safety surveillance (signal detection; signal evaluation; benefit risk assessment; risk mitigation) for all assigned products
  • Labelling support (SmPC / PIL) for assigned product(s)
  • Support production of
    • aggregate reports (PSURs, DSURs etc.)
    • Risk Management Plans (RMPs) and updated thereof
  • Providing safety expertise for questions/requests from competent authorities
  • Occasionally represent VRM/MDSP in working groups and meetings as required

What we will offer you:-

  • Experience of the pharmaceutical industry
  • Professional development and comprehensive training
  • The chance to gain a deeper understanding of pharmacovigilance
  • A competitive salary, discretionary bonus and private medical insurance

We are seeking an individual who is currently studying for a Life Sciences related degree and looking for a one year work placement. The successful candidate should have an interest in Pharmacovigilance, excellent communication and organisational skills, attention to detail and be a committed team player. The role involves building strong relationships across the business, and you will therefore have excellent interpersonal and written skills, with the ability to establish credibility with people at all levels of the organisation.

How to apply:-

Please email your CV, together with a covering letter, clearing stating why you would like to work within our organisation and what has attracted you to this placement in particular, to Suzanne Watson, Human Resources Department, Suzanne.Watson@mundipharma-rd.eu

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