Drug Safety Associate
A strong succession pipeline of contractors has been identified however relevant applications are welcomed.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceuticals, LLC and Actelion Pharmaceuticals Ltd are legal entities of the Janssen Pharmaceutical Companies.
Janssen Research & Development discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, and cardiovascular and metabolic diseases.
We are recruiting for a Drug Safety Associate to join the Global Drug Safety Organization to support our pulmonary hypertension therapeutic area.
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 Analysis of Similar Events
- Perform quality review of Individual Case Safety Reports (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 Global Case Receipt and/or Global Medical Safety Operations Physicians (GMSOP) 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 updates for accuracy
- Vendor oversight activities for assigned products
- Product portfolio subject matter experts
- Operational management activities for onshore teams and vendors, including but not limited to: workload and productivity monitoring activities, workload meetings, vendor meetings, monitoring quality of ICSRs
- Completion of all assigned training on company and Global Medical Safety Operation (GMSO) procedural documents relating to case processing
- Completion of training relating to relevant Pharmacovigilance (PV) Agreements for assigned products
- Participate in designated activities to support revision/creation of case processing procedural documents
- Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)
- Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
- Licensed Practical Nurse with Bachelor’s degree, or with knowledge of pharmacovigilance usually exhibited by 2-4 years’ experience in pharmaceutical safety-related role
- 3-5 years’ 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
Required skills, abilities and competencies include:
- Understanding of medical terminology and ability to summarize medical information
- Ability to follow guidelines and procedural documents (experience of working with Standard Operating Procedures (SOPs) etc. preferred)
- Oriented to quality, attention to detail and accuracy
- Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines
- Ability to work both independently and in collaboration with others
- Proactive approach/uses own initiative appropriately
- Decision-making and problem-solving skills
- Flexibility and adaptability
- Positive attitude
- Good verbal and written communication skills
- Good computer skills (Word, email) and familiarity with safety systems
- Knowledge or experience with Excel, PowerPoint, Visio preferred
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)