Senior Safety Scientist - Safety Writing
- Experience Level
- Experienced (non-manager)
Responsible for leading the completion of Medical/Safety reports/analyses with high quality standards in a cross-functional environment.
As part of the Global Safety Writing Team, the senior safety writer will also be in charge of the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines, attending client audits and regulatory inspections as well as ensuring that Medical/Safety writing activities follow the contracted tasks in SOW or applicable procedural documents.
Specific job duties:
- Leads and coordinates activities from the initiation to the completion of the assigned Medical/Safety writing projects
- Schedules and leads teleconferences/meetings related to the assigned project execution
- Prepares timelines and tracks production and collection of deliverables related to the assigned projects
- Ensures assigned projects are conducted in concert with UBC SOPs, project-specific procedures and client’s SOPs as appropriate
- Participates in client safety signal management process
- Collects, reviews and quality control of safety data
- Assists with the preparation of safety assessments strategy.
- Prepares, reviews and quality controls of periodic safety reports and other safety reports
- Maintains quality control documentations up to date
- Assists with the preparation of periodic safety preparation plans (PSRPs)
- Ensures all processes as described are operational
- Assists in evaluation and validation of systems to support safety
- Actively contributes to preparations of audits and regulatory inspections
- Attends client audits and regulatory inspections to support, present or address topics related to aggregate/safety reporting
- Provides and assists with appropriate documentation of non-compliance with regulatory requirements and / or applicable procedures in Safety Incident Reports (SIRs), Problem Notification Forms and Corrective and Preventive Actions (CAPA) as required
- Collaborates with UBC PV Management to update or design project process improvements
- Escalates to UBC PV Management when activities fall outside contracted tasks in SOW or applicable procedural documents.
- Alerts PV management for any identification/escalation of issues
Desired Skills and Qualifications:
- Pharmacist, Master’s degree or beyond (PhD) in a science or health-related field
- Excellent knowledge of global and local Pharmacovigilance Regulations and Guidelines for both pre and post marketing
- Minimum of 3 years of experience in a pharmaceutical company or a service provider (e.g. CRO)
- Minimum of 2 years of experience in Medical/Safety writing preferably in periodic aggregated reports or signal assessment reports
- Experience in preparation of Risk Evaluation and Mitigation Strategy (REMS) and KAB surveys
- Experience in screening of scientific literature is preferred
- PV experience should include drugs. Experience with safety surveillance of vaccines, biologics and medical devices a plus but not required.
- Experience with case processing including use of coding dictionaries, case narratives or expedited reporting is a plus.
- Proficient with computer programs (Microsoft Outlook, Word, PowerPoint, Excel)
- Good communication, interpersonal interaction, and organizational skills are essential
- Ability to manage multiple client projects simultaneously with good time management skills
- Fluent in English, additional language fluency a plus, but not required
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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