Key Role Activities

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

Assist in the quality review of data captured in the Global Safety Database

Continual monitoring and assessment of report ability 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

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 Number:

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

Complete annual Drug Safety and HCBI Awareness training

Report Adverse Events and complaints in a timely way to Drug Safety according to current Adverse Event Reporting guidelines/SOP and to maintain Regulatory compliance

Essential Technical Knowledge, skills and experience

* 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 Experience

* Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable

* 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

Additional information about the process

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services