Drug Safety Associate Job

Job description

Drug Safety Associate-1500040725WDescriptionJanssenAt 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 AssociateLocation: UK , High WycombeGCF: 24Closing date: Monday 8th June 2015What 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 other designee (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 responsibilitiesActivities may include project involvement, technical training, shadowing and/or mentoring others, soft-skill developmentQualifications
- Registered Nurse or Pharmacist (NB: Certification/licensure is required e.g. RN, RPh, PharmD).
- Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification).
- Licensed Practical Nurse with Bachelors degree, or with knowledge of pharmacovigilance usually exhibited by experience in pharmaceutical safety-related role.
Pharma Experience:
- Experience in pharmaceutical safety related areas preferredWe respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Janssen, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High WycombeOrganization: Janssen Cilag Ltd. (7360)Job Function: Drug & Product Safety Operations