• *Summary**
Prevail InfoWorks focuses on eClinical technology products including Clinical Data Integration, Clinical/Operational Risk-Based Data Analytics and Dashboards, eDC, eTMF, Safety System, IxRS/RTSM, CTMS, Investigator Grant Management and Clinical Budget Management. We provide these products in a SaaS model with world-class delivery, support and related clinical operations services.
The Philadelphia based company has a 15+ year track record of exceeding expectations and earning repeat business with its global biotech, biopharma, device and diagnostics customer base.
We are expanding our Clinical Safety team with people who have drive, creativity, self-motivation, and professionalism. We are seeking Clinical Safety Associates with a minimum of five years experience.
The Pharmacovigilance Analyst II will provide technical and process-related support to Prevail’s pharmacovigilance and medical monitoring activities, ensuring compliance with relevant global regulations and Standard Operating Procedures (SOPs).
• *Responsibilities:**
• Management of safety cases and reports from all sources, including case intake/triage, data entry, quality review, medical review, and follow up activities
• Electronic documentation and filing of safety information according to SOPs and safety management processes
• MedDRA coding of data in the safety database
• Preparation of case narratives
• Reconciliation of the clinical and safety databases
• Provide support for regulatory submission preparation and review
• Coordinate safety project setup, including safety database build
• Author sponsor/project specific safety management plans
• Conduct and assess literature searches
• Participate in sponsor/investigator meetings as required
• Maintain a working knowledge of the safety database
• Maintain working knowledge of global regulatory rules and regulations, including monitoring for new or changing regulation
• Perform other duties as assigned
• *Job Qualifications**
Knowledge and Experience
• Pharmacovigilance knowledge and experience including safety case processing for clinical trials (drugs, biologics, vaccines, and medical devices). Nursing experience is a plus.
• Proficient in MS Office and Adobe Acrobat
• Good Understanding of MedDRA & WHODrug Global dictionaries
• Must display analytical and clinical skills
• Requires narrative writing skills
Education
Degree in Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
Supervisory Responsibilities
None
Competencies
To perform the job successfully, an individual should demonstrate the following competencies:
• Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.