Drug Safety Manager & QPPV

Hobson Prior are currently working with a medium size leading Clinical Research Organisation who are seeking a Drug Safety Manager & QPPV to join them on a permanent basis in Stockholm.

Job Responsibilities:

• You will have responsibility of handling SAEs in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database.
• Review and approval of processed cases, AE/SAE reconciliation and safety coding.
• QPPV responsibilities.
• Overview of safety activities in the department.
• Responsible for plans/instructions and SOPs for post approval surveillance.
• Overlook that assigned projects and tasks in the unit are performed in accordance with current routines, methods, SOPs and current legal requirements.
• Lead relevant project groups/meetings.
• Initiate and lead internal improvement project with other relevant departments.
• Represent as a Project Lead for Safety-only projects.
• Actively contribute to the organization and development of routines/processes to enhance the work at the organisation.
• Responsible for the updates of templates for safety handling in specific studies/projects according to relevant SOPs.
• Oversees the validation of computer applications specific for the department with respect to drug safety requirements.
• Ensure that new processes are implemented within the unit.
• Being well-informed and updated on regulations, directives and guidelines concerning handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues.
• Line management for staff in the Drug Safety Unit.
• Coach, support and mentor staff.
• Responsible for the education and supervision of new Drug Safety personnel.

Key Skills:

• Can work independently as well as in a team matrix organization with little or no supervision.
• Strong written and verbal communication skills.
• Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus.
• Demonstrate ability to lead, mentor, educate and supervise Drug Safety personnel.
• Able to work in a fast-paced environment with changing priorities.

Requirements:

• Bachelor's Degree, preferably in life science or nursing; or equivalent.
• A minimum of 10 years of relevant experience.
• Understand the medical terminology and science associated with the assigned drugs and therapeutic areas.
• Understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.