Janssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting a Senior Drug Safety Associate, Literature to be located in primary Horsham, PA, with consideration of High Wycombe, UK or Raritan, NJ and may require up to 10% travel.
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.
The Senior Drug Safety Associate, Literature will be responsible for the literature review and identification of potential 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. You will be a Process & Product Expert and act as key contact or point of expertise for team members and external contacts for designated products or processes.
You will also be responsible for the following:
- Perform assessment and annotation of literature from global weekly searches, including storage of documentation in a repository
- Mentor of Literature Search and Review team (or other identified) vendor staff, and involvement in recruitment, training, and supervision
- Triage of incoming references to prioritize for daily workflow management Confirmation of literature case registration/committal information by Case Receipt and Case Processing staff .
- Supervise Daily Workload: Prioritization and organization of team workload to maintain regulatory compliance and quality standards
- Participate in GMSO projects, preparations for audits and inspections.
- A minimum of a Bachelor’s or equivalent University Degree is required .
- PharmD or Master in Library/Information Science (medical), Health, Biomedical or related sciences is strongly preferred
- An LPN with knowledge of pharmacovigilance and 5 years’ experience in pharmaceutical safety-related role, is required.
- A minimum of 2 years pharmaceutical industry experience is required.
- Experience in pharmaceutical safety related areas is also required.
- Case processing experience is strongly preferred
- Knowledge and experience with safety reporting and regulatory compliance is required.
- Experience of international safety reporting/regulations are preferred.
- Practical knowledge of global regulatory pharmacovigilance requirements is also required.
- Understanding of medical terminology and ability to summarize medical information
- Ability to follow guidelines and procedural documents is required; experience creating SOP’s strongly preferred.
- Ability to prioritize, plan and organize work assignments, and able to work under strict timelines is required.
- Project Management skills preferred.
- Ability to work both independently and in collaboration with others is also required
- Familiarity with safety systems is required
- Knowledge or experience with Excel, PowerPoint, Visio is required.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary LocationNorth America-United States-Pennsylvania-HorshamOther LocationsEurope/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-RaritanOrganizationJanssen Research & Development, LLC. (6084)TravelYes, 25 % of the TimeJob FunctionDrug & Product Safety Operations
Internal ID: 00001BOW
Location/Region: Horsham, PA (US)