Safety Support Specialist
- Experience Level
- Experienced (non-manager)
This position is available office based in London (UK), Geneva (Switzerland), or Blue Bell, PA (United States)
This position is primarily responsible for supporting all operational functions within the Pharmacovigilance Department including, but not limited to expedited and periodic reporting to regulatory authorities, compliance monitoring, safety regulatory intelligence.
- Bachelor's Degree in a science or health-related field, pharmacy or nursing OR minimum of 1 year of experience in pharmacovigilance/regulatory operations in a pharmaceutical company or in a service provider.
- Comprehensive knowledge of global and local pharmacovigilance Regulations and Guidelines (e.g. EMA, ICH and FDA) both clinical and post marketing.
- Knowledge of vaccine and medical device regulations a plus
- Knowledge of safety database, regulatory electronic reporting tool preferred.
- Experience with regulatory submission a plus but not required
- Good communication, interpersonal interaction, and organizational skills
- Good presentation and training skills
- Ability to manage multiple client projects and tasks with good time management skills
- Proficient with computer programs (Word, PowerPoint, Excel)
- Must be able to speak and write fluently in English
Specific Job Duties:
- Ensure timely reporting /distribution of safety reports/periodic safety reports (DSUR, PSUR, 6 monthly line listings…), monitor and track compliance to competent authorities or partners
- Prepare regulatory submission compliance metrics/reports (Monthly, Quarterly and yearly) and ensure appropriate documentation when deficient (i.e. safety incident report, Problem notification form, corrective and preventive action) at project and UBC level
- Responsible for Safety Regulatory Intelligence monitoring, recording, communication and knowledge maintenance
- Ensure Quality Control activities for regulatory submissions, compliance and safety regulatory intelligence
- Prepare and follow to completion (including user acceptance testing) the safety database configuration requests (regulatory destination and reporting rules) for UBC management review and approval
- Assist with the preparation of relevant project specific plans and procedures and other plans linked to expedited reporting as required and assigned by PV management
- Maintain an in-depth knowledge of the relevant safety database and regulatory electronic reporting tool
- Participate in project specific internal teleconferences/meetings and clients specific TC/meetings for operations
- Support client audit and regulatory inspection as required
- Other duties as 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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