Drug Safety - Student Placements(Job Number: 00000T8I)
Description
Drug Safety Industrial Placement
Duration: 12 months starting June/July 2015
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:
Drug safety scientists collect and evaluate information from patients and healthcare professionals to try and identify new information about the use of medicines and any side effects experienced by patients.
Safety monitoring of medicines is a continuous process, it is performed during clinical trials when medicines are developed, once medicines are launched (also called ‘licenced’) and throughout the entire period where a medicine is available for patients to use. The team is the first point of contact within the company for incoming adverse event reports. The department also monitors our pharmaceutical products across their lifecycle, from clinical trials through to post-marketing surveillance, in order to detect, assess, understand and prevent adverse events. Ultimately the team works to evaluate drug efficacy and maintain patient safety.
You will join our Pharmaceutical business in the role of a Drug Safety Scientist and will be given a high level of exposure to many aspects of the Pharmacovigilance division. This is an exciting and unique opportunity to be at the forefront of drug development in one of Europe’s fastest growing top ten pharmaceutical businesses.
Sector(s):
Pharmaceuticals
Location(s):
High Wycombe, Buckinghamshire
Main duties and responsibilities:
- Support the coordination of safety reporting requirements as required for MAH and/or study sponsor, as applicable
- Responsible for the collection, review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study, Local Health Authorities (LHAs) and other potential sources
- Assist with initial quality review and assessment of individual cases
- Ensure availability as back-up for business and non-business hours contacts
- Co-ordinate/perform the follow-up of missing information from the AE reporter
- Assist in the provision of local data as required supporting the preparation of Safety Summary reports (PSURs, ASR, etc.)
- Assist in the implementation of compliance standards and facilitate the collection of compliance metrics as required
- Ensure that day-to-day Pharmacovigilance functions are performed satisfactorily and that full regulatory compliance is maintained at the Local Operating Company (LOC) level
Qualifications
Requirements of the role:
- 2 years of degree level study completed
- A minimum of 2:1 achieved in first year of study
- Bio science degree types only
Key skills and competencies:
- High level of accuracy and attention to detail
- Passion for working in the pharmaceutical industry
- Excellent communication skills both written and oral
- Seeks opportunities to learn and grow professionally
- Able to prioritise and manage own workload autonomously
- Flexible and adaptable team player
- Self-motivated
- Actively seeks feedback, appreciates and uses constructive criticism
- Bounces back quickly from disappointments and mistakes; learns and moves on quickly
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization: Janssen Cilag Ltd. (7360)
Job Function: R&D
Description
Drug Safety Industrial Placement
Duration: 12 months starting June/July 2015
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:
Drug safety scientists collect and evaluate information from patients and healthcare professionals to try and identify new information about the use of medicines and any side effects experienced by patients.
Safety monitoring of medicines is a continuous process, it is performed during clinical trials when medicines are developed, once medicines are launched (also called ‘licenced’) and throughout the entire period where a medicine is available for patients to use. The team is the first point of contact within the company for incoming adverse event reports. The department also monitors our pharmaceutical products across their lifecycle, from clinical trials through to post-marketing surveillance, in order to detect, assess, understand and prevent adverse events. Ultimately the team works to evaluate drug efficacy and maintain patient safety.
You will join our Pharmaceutical business in the role of a Drug Safety Scientist and will be given a high level of exposure to many aspects of the Pharmacovigilance division. This is an exciting and unique opportunity to be at the forefront of drug development in one of Europe’s fastest growing top ten pharmaceutical businesses.
Sector(s):
Pharmaceuticals
Location(s):
High Wycombe, Buckinghamshire
Main duties and responsibilities:
- Support the coordination of safety reporting requirements as required for MAH and/or study sponsor, as applicable
- Responsible for the collection, review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study, Local Health Authorities (LHAs) and other potential sources
- Assist with initial quality review and assessment of individual cases
- Ensure availability as back-up for business and non-business hours contacts
- Co-ordinate/perform the follow-up of missing information from the AE reporter
- Assist in the provision of local data as required supporting the preparation of Safety Summary reports (PSURs, ASR, etc.)
- Assist in the implementation of compliance standards and facilitate the collection of compliance metrics as required
- Ensure that day-to-day Pharmacovigilance functions are performed satisfactorily and that full regulatory compliance is maintained at the Local Operating Company (LOC) level
Qualifications
Requirements of the role:
- 2 years of degree level study completed
- A minimum of 2:1 achieved in first year of study
- Bio science degree types only
Key skills and competencies:
- High level of accuracy and attention to detail
- Passion for working in the pharmaceutical industry
- Excellent communication skills both written and oral
- Seeks opportunities to learn and grow professionally
- Able to prioritise and manage own workload autonomously
- Flexible and adaptable team player
- Self-motivated
- Actively seeks feedback, appreciates and uses constructive criticism
- Bounces back quickly from disappointments and mistakes; learns and moves on quickly
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization: Janssen Cilag Ltd. (7360)
Job Function: R&D