Drug Safety Assistant-00000RAN
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.
Position Title: Drug Safety Associate
Location: UK , High Wycombe
Closing Date: 10th July 2014
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:
Responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.
Key Responsibilities:
- Triage of incoming cases to prioritize for daily workflow management
- Confirmation of case registration/committal information by Global Case Receipt staff or otherdesignee (e.g. Authorized LSO)
- Completion of remaining case processing, including labelling and narrative writing as appropriate
-
Liaison with Global Case Receipt and/or Pharmacovigilance Physician staff as appropriate to clarify appropriate information required for case processing
-
Other activities relating to case processing as appropriate per case, including but not limited to:-
- Single case unblinding, SAE/AE reconciliation, deviation memo preparation,
deletion/admin edit requests, review protocol update request forms for accuracy Processes & procedures: awareness of and input to company procedures and guidance
-
Completion of all assigned training on company and GMS procedural documents relating to case processing
-
Completion of training relating to relevant PV Agreements for assigned products
-
Participate in designated activities to support revision/creation of case processing procedural documents
-
Project work: participation in assigned projects, including inspection/audit readiness activities
-
Participation in inspections and audits as identified, including interviews and provision of requested data
-
Personal development: continuous development of personal skills whether task or competency-related.
-
Participation in local or global project teams, including on-time delivery of assigned responsibilities
- Activities may include project involvement, technical training, shadowing and/or mentoring others,
- soft-skill development
Qualifications
Education:
• Bachelors degree (or High School graduate/successful completion of ‘A’ levels, with college coursework preferred)
Pharma Experience:
• Three years of pharmacovigilance experience required
• Experience in pharmaceutical safety related areas preferred
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization: Janssen Cilag Ltd. (7360)
Job Function: R&D
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.
Position Title: Drug Safety Associate
Location: UK , High Wycombe
Closing Date: 10th July 2014
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:
Responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.
Key Responsibilities:
- Triage of incoming cases to prioritize for daily workflow management
- Confirmation of case registration/committal information by Global Case Receipt staff or otherdesignee (e.g. Authorized LSO)
- Completion of remaining case processing, including labelling and narrative writing as appropriate
-
Liaison with Global Case Receipt and/or Pharmacovigilance Physician staff as appropriate to clarify appropriate information required for case processing
-
Other activities relating to case processing as appropriate per case, including but not limited to:-
- Single case unblinding, SAE/AE reconciliation, deviation memo preparation,
deletion/admin edit requests, review protocol update request forms for accuracy
-
Completion of all assigned training on company and GMS procedural documents relating to case processing
-
Completion of training relating to relevant PV Agreements for assigned products
-
Participate in designated activities to support revision/creation of case processing procedural documents
-
Project work: participation in assigned projects, including inspection/audit readiness activities
-
Participation in inspections and audits as identified, including interviews and provision of requested data
-
Personal development: continuous development of personal skills whether task or competency-related.
-
Participation in local or global project teams, including on-time delivery of assigned responsibilities
- Activities may include project involvement, technical training, shadowing and/or mentoring others,
- soft-skill development
Qualifications
Education:
• Bachelors degree (or High School graduate/successful completion of ‘A’ levels, with college coursework preferred)
Pharma Experience:
• Three years of pharmacovigilance experience required
• Experience in pharmaceutical safety related areas preferred
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization: Janssen Cilag Ltd. (7360)
Job Function: R&D