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.