|Job title :||PV Associate|
|Location :||West Sussex|
|Job type :||Permanent|
|Salary :||£30000 - £40000 per annum + benefits|
|Contact name :||John Spring|
|Contact number :||+44 (0) 207 255 6650|
|Contact email :||email@example.com|
This position is a permanent role working with a full service CRO specialising in early and late phase oncology trials across Europe, Asia and the US. It is a new position looking for an enthusiastic and hard-working pharmacovigilance professional based in West Sussex.
Salary & Benefits:
Up to £40k depending on experience. Full details on request.
Role and responsibilities:
*Implementation of Safety Management Plans (SMP) specific to study protocol and Sponsor requirements
*Managing receipt and processing of SAE reports according to the Safety Management Plan
*Review SAE reports and any supporting documents for accuracy
*Writing patient narratives
*Coding Serious Adverse Events accurately using MedDRA
*Identify significant missing information from reports
*Ensure cases that require expedited reporting to regulatory agencies are processed within the timelines identified in the SMP
*Provide independent QC of SAE reports processed by the team
*Notify the Sponsor and clinical team of SAEs
*Preparing safety reports for Sponsor approval, regulatory submission and investigator notification
*Submit safety reports to regulatory agencies, Central Ethics Committees and Investigators, as required.
*Maintain study-specific records for SAEs and safety reports
*Coordination of the review of safety data by the Medical Monitors at pre-determined intervals.
*Participation in signal detection, trend and pattern recognition activities
Requires skills and qualifications:
Bachelor's degree in a life science field or equivalent
1-2 years Drug Safety experience or related (required)
Case processing experience (required)
SAE and SUSAR experience (required)
Prior experience of working with clinical databases such as ARGUS (required)
Prior experience in acting as a responsible person/qualified person for Eudravigilance (an advantage)
To apply for this position and put yourself under immediate consideration, send your CV to firstname.lastname@example.org or call +44 (0) 207 255 6650