An exciting opportunity is now available for a Senior Patient Safety Specialist to join an established biopharmaceutical company in Surrey, UK.
As a Senior Patient Safety Specialist, you will be part of the Drug Safety and Epidemiology Team, supporting the operational processes involved with ensuring regulatory compliance. In this position you will look after pharmacovigilance of both marketed and investigational medicines. In addition there could also be staff management responsibilities.
- Ensure all cases meeting strict timelines as defined in global operating procedures are processed daily, aiming for 100% compliance with MHRA requirements at all times
- Evaluate all adverse event information received by company proactively following up cases for completeness, tracking to completion and alerting business (within areas of responsibility) to emerging safety issues and providing input as required
- Reviewing quality of data entry onto safety systems ensuring adherence with global conventions for handling safety data and that optimal outputs attained for health authority and global CS&E striving for continuous quality improvement at all times
- Manage key pharmacovigilance business stakeholders (within business areas of responsibility) ensuring optimal processes in place for transmission of any adverse event information and that any regular reconciliation checks are carried out within timelines specified
- Ensure that departmental and other companypersonnel are aware of their specific role in the clinical safety processes by providing training / refresher training as required
- Maintaining a constant state of readiness for any inspection activity related to business / CSE functional areaof responsibility
- Lead, develop and manage the Clinical Safety Assistants under functional area of responsibility driving compliance activities in particular with respect to timelines and quality
- A key element of this role is the potential to Line Manage – previous experience not required but candidates need to demonstrate Leadership competencies
Qualifications & Experience
- Sound evaluative/analytical skills required for processing complex adverse event cases
- Quality and thoroughness an important feature as cases submitted to health authorities
- Hands-on role with new global drug safety database, so must have good understanding of pharmacovigilance databases
- Sound knowledge of pharmacovigilance (including UK and EC regulations) and high awareness of global nature of drug safety
- Life science or pharmacy degree essential; Diploma in Pharmacovigilance or other postgraduate qualification an advantage
- Proven pharmacovigilance experience is required
- Medical knowledge gained professionally an advantage e.g. pharmacy/nursing
For more information, or to apply for this Senior Patient Safety Specialist job, please contact Hendre Moolman at CK Clinical on +44 (0)1438 743047 or email firstname.lastname@example.org quoting 20932 to indicate your interest.