Senior Drug Safety Scientist-00000PC5
Description
Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson (J&J). Please visit http://www.janssen.co.uk/ for more information.
What type of mark will you make?
Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your experience; express your passion and touch the world
Position Summary:
To ensure day-to-day workload is monitored and managed and that the Head of Drug Safety / Local Safety Officer is kept apprised.
Support the coordination of safety reporting requirements as required for Marketing Authorisation Holders (MAHs) and /or study sponsor, as applicable.
Key responsibilities:
Inbound Case Management
- Coordinates receipt and processing of incoming safety information from multiple sources, both internal and external to the Company
- Coordinates entry of relevant/required safety data into the Global Safety Database from spontaneous sources, clinical trials and other solicited sources.
- Ensures 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
- Coordinates and is responsible for assessment of incoming information from multiple sources, both internal and external to the Company
- Coordinates and is responsible for the quality review of data captured in the Global Safety Database
Outbound Case Management
- Maintains continual awareness of regulatory reporting changes that affect the UK and Ireland.
- Ensures that the reporting rules applied to the GMS safety reporting system(s) are appropriate and up-to-date
- Ensures 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))
- Responsible for quality review of expedited assessments prior to submission
- Coordinates 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 identification/implementation of Corrective and Preventive Actions (CAPAs) to contribute towards sustained reduction in non-compliance.
- Support all occurrences of internal and external audits and inspections
- Ensures all assigned training is completed in a timely manner
- Routinely involved in mentoring/training of Janssen staff and/or third party partners with respect to pharmacovigilance
- Coordinates 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
- Maintains oversight of aggregate reporting responsibilities, periodicity and submissions
- Ensures all cases have been processed accordingly within the required timelines each day
- Routinely involved in projects: locally, regionally and/or globally. May lead some projects.
Responsible for identifying potential continuous improvements and contributing towards procedural documents (local, regional and/or global)
Qualifications
-
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
- Thorough knowledge and understanding of key legislation applicable to pharmacovigilance in the UK and Ireland
- Local Subject Matter Expert in Global Safety Database
Experience
- Biological sciences degree and/or equivalent proven expertise and experience in pharmaceutical regulations and R&D processes
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization: Janssen Cilag Ltd. (7360)
Job Function: Drug & Product Safety Operations
Description
Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson (J&J). Please visit http://www.janssen.co.uk/ for more information.
What type of mark will you make?
Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your experience; express your passion and touch the world
Position Summary:
To ensure day-to-day workload is monitored and managed and that the Head of Drug Safety / Local Safety Officer is kept apprised.
Support the coordination of safety reporting requirements as required for Marketing Authorisation Holders (MAHs) and /or study sponsor, as applicable.
Key responsibilities:
Inbound Case Management
- Coordinates receipt and processing of incoming safety information from multiple sources, both internal and external to the Company
- Coordinates entry of relevant/required safety data into the Global Safety Database from spontaneous sources, clinical trials and other solicited sources.
- Ensures 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
- Coordinates and is responsible for assessment of incoming information from multiple sources, both internal and external to the Company
- Coordinates and is responsible for the quality review of data captured in the Global Safety Database
Outbound Case Management
- Maintains continual awareness of regulatory reporting changes that affect the UK and Ireland.
- Ensures that the reporting rules applied to the GMS safety reporting system(s) are appropriate and up-to-date
- Ensures 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))
- Responsible for quality review of expedited assessments prior to submission
- Coordinates 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 identification/implementation of Corrective and Preventive Actions (CAPAs) to contribute towards sustained reduction in non-compliance.
- Support all occurrences of internal and external audits and inspections
- Ensures all assigned training is completed in a timely manner
- Routinely involved in mentoring/training of Janssen staff and/or third party partners with respect to pharmacovigilance
- Coordinates 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
- Maintains oversight of aggregate reporting responsibilities, periodicity and submissions
- Ensures all cases have been processed accordingly within the required timelines each day
- Routinely involved in projects: locally, regionally and/or globally. May lead some projects.
Responsible for identifying potential continuous improvements and contributing towards procedural documents (local, regional and/or global)
Qualifications
-
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
- Thorough knowledge and understanding of key legislation applicable to pharmacovigilance in the UK and Ireland
- Local Subject Matter Expert in Global Safety Database
Experience
- Biological sciences degree and/or equivalent proven expertise and experience in pharmaceutical regulations and R&D processes
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization: Janssen Cilag Ltd. (7360)
Job Function: Drug & Product Safety Operations