Drug Safety Contracts and Operations Placement

by Mundipharma Research

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Deadline: 3rd April 2015
Salary: Competitive
Length: Placement (10 Months+)
Roles: Business Management
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 Drug Safety Contracts and Operations 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.

In this role, you will be providing comprehensive support to the Senior PV Contracts Manager to ensure that MDSP have accurate and robust pharmacovigilance contracts (or PVAs) in place with the Independent Associated Companies (IACs) and their partners. In addition you will be assisting the Drug Safety Operations team with the processing of adverse event reports from clinical studies, post-marketing studies, spontaneous, regulatory authority and literature report sources.

This role offers a great opportunity to develop both your written and verbal communication skills. Interacting with IACs from Europe, Asia and South America will allow you to develop skills in writing clear and precise correspondence in order to prepare accurate contracts and supporting documentation. You will be responsible for collecting key information, administration within the contracts document management system, and distribution of the final documents to relevant parties for implementation. In addition, data entry of adverse event reports into Mundipharma’s global drug safety database will provide an insight and overview of key pharmacovigilance processes.

Broad purpose of job

Assist the Pharmacovigilance Contracts Manager (PV Contracts Manager) to ensure that Mundipharma Drug Safety and Pharmacovigilance (MDSP) comply with applicable regulatory requirements with respect to pharmacovigilance agreements (PVAs). This means that a current PVA exists where necessary, the PVA is compliant with current pharmacovigilance legislation and good practice, that roles and responsibilities of the Parties are clearly defined, that they contain all the covered products and are written in accordance with the current legal approved MDSP templates. The PVAs are kept up-to-date via amendments or full updates at periodic or adhoc review.

To assist with the case processing for case reports for pre and post marketed products within the Operations team.

Specific duties and responsibilities

  • Assist the PV Contracts Manager to collect necessary basic or update information from the Independent Associated Company (IAC) or business partner in order to initiate PVA work.
  • Assisting with periodic reviews for PVAs with the IACs within PVA COMPASS. This shall include:
    • Initiating the new document;
    • Assisting the PV Contracts Manager to finalise the updated PVA; and
    • Subsequent administration at finalization - collecting signatures, storage of the final PVA (electronically & paper), schedule training, associated administration, etc.
  • Co-ordinate the activities for preparing amendments to PVA documents: prepare the documentation within PVA COMPASS, circulate to relevant parties for review, collate feedback and update as appropriate, co-ordinate finalization process, e.g. collecting signatures, associated administration, etc.
  • Assist the PV Contracts Manager with the administrative processes required for finalization of PVAs with both IACs and third parties, e.g. co-ordinate collection of signatures, completing standard forms to notify relevant parties of key information, upload of signed PVA into PVA COMPASS, scheduling training, etc.
  • Processing of adverse event reports from all source types including:
    • Data entry of non-serious Individual Case Safety Reports (ICSRs)
    • Narrative writing

What we will offer you:-

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

Requirements:-

  • Have good attention to detail
  • Show good initiative and an organised approach
  • Can work without direct supervision and guidance
  • Understanding of medical concepts
  • Good formal relevant writing skills.
  • Excellent communication skills
  • Ability to work in a strongly regulated environment with good learning skills
  • Good time management, with ability to work to tight deadlines
  • Flexible approach and able to prioritise work appropriately
  • Team player
  • Sound decision making and judgment

We are seeking an individual who is currently studying for a business/administration related degree and looking for a one year work placement.

The position would suit an applicant who enjoys working in an operational environment, understands the importance of confidential data and has strong attention to detail and communication skills. Previous experience of working in an office environment is desirable.

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, clearly stating why you would like to work within our organisation, and what has attracted you to this particular placement, to Katie Wheeler, Human Resources Department, Katie.Wheeler@mundipharma-rd.eu quoting reference: KW/RM

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