Product Vigilance Assistant

Posted 23 February by PE Global

PEGlobal are looking for a Product Vigilance Assistant/Drug Safety Scientist for our multinational pharmaceutical client based in the Buckinghamshire area on an initial 12 month contract.

Support the coordination of safety reporting requirements as required for Marketing Authorisation 
Holders (MAHs) and /or study sponsor, as applicable. 

Key Role Activities 

Inbound Case Management 
· Receipt and processing of incoming safety information from multiple sources, both internal 
and external to the Company 
· Entry of relevant/required safety data into the Global Safety Database from spontaneous 
sources, clinical trials and other solicited sources. 
· Provision of safety information/acknowledgement to marketing partners/other third party 
partners/Global Medical Safety within the internal and contractual timelines 
· Requesting additional information from multiple sources, both internal and external to the 
· Assist with assessment of incoming information from multiple sources, both internal and 
external to the Company 
· Assist in the quality review of data captured in the Global Safety Database 
Outbound Case Management 
· Continual monitoring and assessment of reportability of Individual Case Safety Reports 
due for regulatory reporting to the respective Competent Authorities (MHRA and IMB) and 
Notified Bodies (British Standards Institution (BSI)) 
· Quality review of expedited assessments prior to submission 
· Provision of safety information to Competent Authorities/Notified Bodies within required 
regulatory timelines 

Additional Activities 
· Accurate and timely documentation of deviations to process/timelines. Including root 
cause analysis and documentation of Corrective and Preventive Actions (CAPAs) 
· Support all occurrences of internal and external audits and inspections 
· Ensures all assigned training is completed in a timely manner 
· May be involved in mentoring/training of the companies staff and/or third party partners with 
respect to pharmacovigilance 
· May be assigned as key contact for studies or partner contracts 
· Support Head of Drug Safety/LSO in responding to ad hoc requests as required 

Ideal Background and Knowledge of the successful candidate
· Awareness of and familiarity with industry principles of drug development and 
· Proficiency in global and local SOPs 
· Computer literate with expert knowledge of the Global Safety Database and/or expedited 
reporting module(s) 
· Ability to prioritise and work to strict timelines on a daily basis 
· Excellent verbal and written communication skills 
· Ability to negotiate and communicate with internal and external customers’ 
· Ability to work effectively as a member of the Drug Safety and broader Medical 
· Knowledge and understanding of key legislation applicable to pharmacovigilance in the 
UK and Ireland 
· Proven expertise and experience in pharmaceutical regulations and R&D processes is

  • Degree-level qualification (ideally in life sciences) or equivalent nursing qualification 
  • Registration with official governing bodies e.g. General Medical Council, Royal Society of Pharmacists 

Reference: 34546958

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