Safety Data Associate
- Experience Level
- Experienced (non-manager)
This position is primarily responsible for supporting all operational functions within the Global Pharmacovigilance department.
- Bachelor's Degree in a science or health-related field, pharmacy or nursing OR minimum of 1 year of experience in pharmacovigilance/medical/health care operations in a pharmaceutical company or in a service provider or in medical settings.
- Good communication, interpersonal interaction, and organizational skills
- Ability to manage multiple client projects simultaneously with good time management skills.
- Proficient with computer programs (Microsoft Outlook, Word, PowerPoint, Excel) .
- Must be able to speak and write fluently in English
Supervisory Responsibilities: None
Specific Job Duties:
- Is responsible for the monitoring on a daily basis of the PV mailboxes, fax machines sharepoints/portals and acknowledging receipt of safety case reports.
- Is responsible for Book-in, duplicate check and accurate full Data Entry of safety case reports into safety database in a timely manner.
- Generates draft case narrative as assigned by UBC PV Management
- Produces assigned work at high quality and according to timelines.
- Assists in the preparation and quality control of periodic safety reports, as assigned by UBC PV Management
- Assists in the timely distribution of safety reports to Health Authorities, clients and client partners, in the appropriate format.
- Assist in sending and tracking follow up queries for safety case reports in a timely manner.
- Ensures filing of safety case reports and other project-related documents, as required.
- Assists in the timely and accurate completion of reconciliation activities.
- Assists in the timely identification of Safety Reports and/or relevant safety information during the monitoring of the literature, as assigned by UBC PV Management.
- Attends UBC PV Department meetings.
- Participates in project specific teleconferences/meetings.
- Other duties assigned by management.
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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