Senior Pharmacovigilance Associate

Capital Pharma
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
Sr. Pharmacovigilance Associate
Location: Cambridge
Permanent, full-time

About the Role:

Working in our global Pharmacovigilance Department the candidate will responsible for and gain exposure to many different aspects of Pharmacovigilance.

* Case processing from case registration through to submission and assisting with case management
* Literature reviews
* Production and review of documents detailing PV processes
* Involved in the production and review of various safety documents (including PBRERs and DSURs)
* Mentoring and supporting of new and existing departmental staff
* Attendance at cross functional meetings as PV representative, giving and receiving any PV specific information as required
* Researching and assessing the impact of new PV regulations/GVP information on department processes
* Reviewing and coordinating MedDRA and WHO drug coding in Clinical Studies
* To lead / project manage SAE reconciliation activities for assigned studies in accordance within the defined timelines
* To be the primary PV contact for assigned studies and to ensure study timelines and work activities are communicated in a timely manner
* To lead / project manage SAE narratives for CSR's and other PV specific reports for assigned studies in accordance within the defined timelines
* Maintaining a strong GPVP/GCP knowledge


* The candidate should be life science degree qualified and demonstrate progressive professional development in Pharmacovigilance
* Requires a good operating knowledge of Pharmacovigilance databases including query by example searching. Also strong Microsoft Word, Excel, Adobe Acrobat and Power Point
* Strong experience of analysing and writing major pharmacovigilance safety reports, with extensive experience of case processing and assessment