Safety Surveillance Manager

Recruiter
GW PHARMA LTD
Location
Cambridge, Cambridgeshire
Salary
Undisclosed
Posted
22 Sep 2016
Closes
17 Nov 2016
Sectors
Management
Contract Type
Permanent
Hours
Full Time

Safety Surveillance Manager

Cambridge, UK

The Role      

The role holder is responsible for the management of safety surveillance activities for GW's human medicinal products in both the pre- & post marketing setting.

Key Responsibilities

  • Support the QPPV for safety surveillance and signalling
  • Actively manage and run the safety surveillance meetings
  • Organising and scheduling Pharmacovigilance analysis of data
  • Undertaking data analysis and writing of safety reports
  • Line management
  • Database searches
  • Analysis of similar events
  • Issue work-ups
  • Information requests and responses
  • Actively maintain product core safety information 
  • Maintaining a strong GPVP & GCP knowledge.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job

Essential Skills & Experience

Knowledge:

  • Full understanding of clinical trials and the drug development process.
  • Life sciences degree with a sound clinical knowledge in diverse therapeutic areas
  • Strong background in drug safety / pharmacovigilance and safety signal analysis
  • Thorough knowledge of safety regulations and legal requirements
  • Extensive pharmaceutical safety experience.
  • Report writing and benefit risk analysis (pre- & post marketing) including aggregate report writing and issue work-up reports
  • Analysing safety data and writing responses to safety questions

Skills:

  • An experienced manager
  • Proficiency in safety databases and medical coding
  • Excellent communication skills including the ability to work with people at all levels.
  • Excellent organisational and time management skills.
  • Ability to be proactive, work on own initiative as well as part of a team.
  • Good attention to detail.

Attributes and Behaviours:

  • Have the ability of prioritising, planning and organising workload.
  • Maintain a positive working environment within the office
  • Demonstrate a “can do” approach.
  • Demonstrate highest level of confidentiality and discretion
  • Willingness to travel if required.

Desirable Skills & Experience

  • Experience of risk management activities & preparing Risk Management Plans

Location: Cambridge, UK

To apply, please send your C.V, cover letter and salary expectations to recruitment@gwpharm.com by clicking apply.

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