PV Scientist

Key People

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Job ID :

15034


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Master of Science


Address 1 :

United Kingdom,--Reading,Reading,


Key Skills :

contract, drug safety, pv, pharmacovigilance, DS, scientist


Salary :

£20.00 - £25.00 per hour


Date Posted :

18 Jun, 2019



Company Name :

Key People


Location1 :

Reading




Job Category :

Drug Safety Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

The Pharmacovigilance Scientist will be responsible for the timely case management of spontaneous and clinical trial reports including the data entry, QC, follow-up, E2b electronic reporting of adverse reactions received from worldwide sources; in addition, reporting of events to Ethics Committees and Investigators. This will involve liaising with global pharmacovigilance colleagues including CROs to ensure that the events have been entered correctly and submitted successfully to European regulatory authorities. It is beneficial that the Pharmacovigilance Scientist has prior working knowledge of the regulatory reporting requirements in Europe and a thorough understanding of all case processing activities from pre and post marketing sources. The Pharmacovigilance Scientist will also be required to assist with the preparation of 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 into 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
*Performs timely E2b electronic reporting to the EMA and EU regulatory authorities
*Performs case reconciliation activities
*Assists in the Preparation of Pharmacovigilance SOPs and Work Instructions
*Assists 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 or nursing 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 case processing issues as required
*Ability to take ownership of assigned cases
*Previous experience of using safety databases is essential - Argus safety preferable

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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