Job Reference: 24339
Job Duration: 9-12 months
Start date:
Description:
My pharmaceutical client in the Berkshire area is looking for aPV Scientist on a part time contract basis for 9-12 months.
The Pharmacovigilance Scientist will be responsible for the casemanagement of spontaneous and clinical trial reports such as the data entry, QC, follow-up, E2b electronic reporting of adversereactions received from worldwide sources and reporting of events to Ethics Committees and Investigators. This will involve working with with global pharmacovigilance colleagues including CROs to make sure that the events have been entered effectively andsubmitted correctly to European regulatory authorities. It is advantageous that the Pharmacovigilance Scientist has previous working knowledge of the regulatory reporting requirements in Europe and an in depth understanding of all case processing activities from pre and post marketing sources. The Pharmacovigilance Scientist will also be tasked with assisting in the preparationof the procedural documentation for European pharmacovigilance and clinical safety activities.
Job Duties and Main Responsibilities:
*Case management of reports from all sources
*Triage, data entry and QC of case reports for the global safety database*Review of case reports, identify follow-up, compile follow-up queries
*Preparation of case narratives and performs MedDRA coding
*Coordinates medical review and follow-up of case reports
*Undertakes timely E2b electronic reporting to the EMA and EUregulatory authorities
*Carries out case reconciliation activities
*Helps in the Preparation of Pharmacovigilance SOPs and Work Instructions
*Helps with the Clinical safety activities e.g. preparation of Safety Management Plans, SAE Reconciliation Plans, templates; reporting to Ethics Committees, Investigators
*Participates in process improvements and any other projects assigned by the Pharmacovigilance Manager
*Maintains good up-to-date knowledge on European pharmacovigilance regulations, particularly associated with electronic reporting
*General administration as required
Qualifications and Experience:
*Life Sciences ornursing degree
*Minimum of one to two years' prior experience in pharmacovigilance
*Good working knowledge of EU pharmacovigilance legislation and clinical safety requirements
*Good experience in the case processing of events
*Excellent coding and narrative writing skills
* Understanding of EudraVigilance E2b transmission and acknowledgement messages
*Ability to evaluate reports and draw conclusions independently
*Ability to prepare clear, concise and unambiguous pharmacovigilance documentation
*Ability to interact effectively with Regulatory authorities
*Ability to interact effectively with global offices to resolve caseprocessing issues as required
*Ability to take ownership of assigned cases
*Previous experience of using safety databases is essential - Argus safety preferable
Attributes:
*Excellent verbal and written skills in English
*Ability to work under pressure with minimal supervision
*Proactive attitude and ability to work on own initiative
*Excellent organisational skills and attention to detail
*Good time management skills
*Demonstrated knowledge of Microsoft Word and Excel is essential
*Flexibility in ensuring the pharmacovigilance requirements are met
If this may be suitable or of interest, please apply and get in touch with Ross Wilson at rwilson@keypeople.co.uk
Industry: Pharmaceuticals
Salary: £15.00 - £20.00 per hour
Salary Benefits:
Vacancy Type: Contract
Job Skills: Drug Safety, Pharmacovigilance, Pharmaceutical, Case Processing, PSURs, PBRERs
Contact Name: Ross Wilson
Website: -
Direct Application URL: -