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Associate Drug Safety Director- Pv
4 months ago
**Associate Safety Director**
**12 Month FTC**
**Hybrid working
- only in office when business requires**
**FT 37.5hours, rate is £80 - £100 Ltd/UMB per hour or £59.67 - £74.58 PAYE basic (excluding holiday pay)**
**Hertfordshire area, UK**
REED Scientific are representing a global pharmaceutical company whose achievements help to transform the lives of millions of people. Their UK site is a key part of their global research and development programme.
**About the Job**
? Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas. Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategiccontext (e.g., disease under study, safety profile of competitors, mechanism of action)
? Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
? Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality)or in response to Regulatory Authority requests
? Contribute to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy
? Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including the IB), risk communications, RMP, REMS
? Contributing to study management from a safety perspective through SMT/PET activities and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS
? Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
? Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
- Minimum Qualifications: Qualified healthcare professional or Life Sciences graduate. Preferred Qualifications: A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications)would be advantageous.
- Principal Scientist (lvl 3): 4 or more years of drug development experience in the pharmaceutical or related industry including at least 2 years in drug safety or a closely related field.
- Understanding of GxP and regulated processes and end to end clinical trial lifecycle
- Application of project management methodology
The company is offering a competitive salary as well as a supportive and inclusive culture, with a strong focus on employee development. Plus, you will be part of an amazing team
If this looks of interest and you meet the requirements, don’t miss this opportunity
