Drug Safety Associate (1 of 3)
Janssen Research & Development, a part of the Johnson & Johnson family of companies, is recruiting for a Drug Safety Associate to be located in Horsham PA or Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Drug Safety Associate is 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.
Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness
- Triage of incoming cases to prioritize for daily workflow management
- Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval
- Preparation of SUA summary: Analysis of Similar Events
- Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
- Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) 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, Serious Adverse Event (SAE) /Adverse Event (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 GMSO 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 local or global project teams, including on-time delivery of assigned responsibilities
- 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. Activities may include project involvement, technical training, shadowing and/or mentoring others, soft-skill development.
Perform other related duties as required
- Mentoring of other DSAs or staff, as identified
- Maintains compliance with company guidelines and HR Policies
- Registered Nurse OR Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification) OR Associates Degree in Nursing or relate scientific area OR Licensed Practical Nurse without Bachelor's degree, but with knowledge of Drug Safety usually exhibited by minimum 5 years' experience in a pharmaceutical safety-related role is required
- Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas.
- Case processing experience is desired
- Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
- Understanding of medical terminology and ability to summarize medical information is preferred
- Ability to follow guidelines and procedural documents (experience of working with SOPs etc.) is preferred
- Familiarity with safety systems is preferred
- Knowledge or experience with Excel, PowerPoint, Visio is preferred
North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
Drug & Product Safety Operations
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