Description
To support the operational processes involved with ensuring that UK complies with strict regulatory requirements for pharmacovigilance of both its marketed and investigations medicines.
1. 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
2.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
3.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
4.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
5.Ensure that departmental and other company personnel are aware of their specific role in the clinical safety processes by providing training/refresher training as required
6.Maintaining a constant state of readiness for any inspection activity related to business/CSE functional area of responsibility
7.To lead, develop and manage the Clinical Safety Assistants under functional area of responsibility driving compliance activities in particular with respect to timelines and quality (* Not mandatory for role)
Background
Education: Life science or pharmacy degree essential; Diploma in Pharmacovigilance or other postgraduate qualification an advantage
Experience: At least two years pharmacovigilance experience required; Medical knowledge gained professionally an advantage eg pharmacy/nursing
hy-phen Limited is acting as an Employment Business in relation to this vacancy.