Drug Safety Scientist

Drug Safety Scientist

The role is to support and coordination of safety reporting requirments as required for Marketing Authorisation Holders (MAHs) and or study sponsor applicable.

Responsibilities:

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 Company
• 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 40

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 40

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 Janssen staff and/or third party partners with respect to pharmacovigilance
• May be involved in completion of periodic reconciliation activities
• May be assigned as key contact for studies or partner contracts
• Support CSTL / LSO in responding to ad hoc requests as required 20
  

EDUCATION & EXPERIENCE REQUIREMENTS:
Essential Knowledge & Skills

• Awareness of and familiarity with industry principles of drug development and pharmacology
• 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 Department teams
• Knowledge and understanding of key legislation applicable to pharmacovigilance in the UK and Ireland

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