Drug Safety Scientist - Maidenhead

Drug Safety Scientist - Maidenhead - 18Months

* 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

* 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

* 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 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

* Acts in accordance with Johnson & Johnson HCC requirements if interacting with Healthcare Professionals

Essential Knowledge & Skills

*Awareness of and familiarity with industry principles of drug development and pharmacologyProficiency 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

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

Qualifications

* Degree-level qualification (ideally in life sciences) or equivalent nursing qualification

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

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.