PV Officer
- Full-time
- Department: ICSR Management
Company Description
PrimeVigilance, an Ergomed brand , was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects.
Ergomed Plc is a public company on the London stock exchange with its HQ in Guildford, UK. The company boasted 40% growth in its revenues in its last report. This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients.
Job Description
Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management
Contributes to achieving company´s goals and objectives
Works independently
Providing support to other activities undertaken by the project team on behalf of the client and the company
Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
· Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
· Performing ICSR follow up
· SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
· Reconciliation (clinical, partners)
· Personal data protection
· Product Quality Complaint handling and interaction with Quality Assurance
· Medical Information interaction
· MedDRA and WHO coding
· Database Outputs and Reports (including data for monthly reporting to clients)
· Workflow & resource management
Line Management tasks (periodic appraisals, performing vacation approval, ensuring adequate cover is in place to meet operational requirements for existing and new contracts)
Mentoring and training of new and more junior employees within the department
Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
More senior colleague may perform tasks assigned as per SOP to more junior position
Performing activities in the scope of ICSR management unit within agreed extent and timeframe
Qualifications
Education
Life science graduate, pharmacy, nursing or other healthcare related qualification
Experience
2-5 years of work experience in pharmacovigilance
Special Skills
Organization skills, including attention to detail and multitasking
Management skills, including time and issue management
Communication skills
Presentation skills
Ability to motivate/coach people; leadership
Language Skills
English - advanced (spoken, written)
PC Skills
Advanced literacy (MS Office)
Additional Information
All your information will be kept confidential according to EEO guidelines.
Our Offer:
- Work within a successful, highly – qualified and dynamic team
- Professional training and career development in a fast-growing healthcare company