What are the responsibilities and job description for the Safety Scientist position at United BioSource?

As a pharmaceutical support industry leader , UBC is devoted to empowering health solutions for a better tomorrow . We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC as a Safety Scientist! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values of Collaboration, Conscientiousness, Curiosity, Compassion and Consultation. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

This position is responsible for supporting all operational functions within the Global Case Processing unit including, but not limited to, safety report case processing and reporting, global and local literature review, assisting with project start-up, training and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines.

Requirements :

Bachelor's Degree in a science or health-related field, pharmacy or nursing required.
Minimum of 1 year of experience in a pharmaceutical company or a service provider (e.g. CRO) with case processing responsibilities.
Good knowledge of global and local pharmacovigilance (PV) regulations and legislation, both pre-and post-marketing required.
Case processing experience should include drugs. Experience with safety surveillance of vaccines, biologics and medical devices a plus but not required.
Proficient with case processing including use of coding dictionaries and case narratives writing, preferably within Argus.
Experience with other PV databases (e.g. ARISg) a plus, but not required.
Experience in expedited reporting a plus, but not required.
Experience in global and local literature review a plus, but not required.
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, and Excel).
Must be able to speak fluent English.

Supervisory Responsibilities :

None

Specific Job Duties :

Responsible for processing and evaluating (i.e. narrative writing, seriousness, causality and expectedness assessment) safety reports originating from clinical studies, literature and the post marketing experience for client products.

Responsible for the timely completion of safety reports for distribution to Health Authorities, clients and client’s partners.

Responsible for the timely identification of Safety Reports and / or relevant safety information during the monitoring of the literature.

Responsible for Quality Control of Case Processing and Literature Review deliverables.

Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to : safety reports, aggregate data, line listings.

Ensure the timely and accurate completion of case processing due diligence activities.

Ensure the timely and accurate completion of PV reconciliation activities.

Assist in the reconciliation of clinical and safety databases.

Prepare and follow through to completion the Safety Database requests (case deactivation, Output Request, Change Control and User Access Request Forms as appropriate) for UBC PV management review and approval.

Assist, in conjunction with the Argus team and UBC PV management, in User Acceptance Testing (UAT), including, but not limited to, coordination, generation, and execution of test scripts.

Assist with the preparation of relevant project specific plans and procedures and other plans linked to case processing and literature activities as required and assigned by UBC PV Management.

Participates in project specific internal teleconferences / meetings and client specific teleconferences / meetings for operations.

Escalates to UBC PV Management when activities fall outside contracted tasks in Scope of Work (SOW) or applicable procedural documents.

Provide and assist 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.

Support in client audits and regulatory inspections from a pharmacovigilance operations standpoint.

Other duties as assigned by UBC PV Management.

Benefits :

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.

Here are some of the exciting perks UBC offers :

Remote opportunities

Competitive salaries

Growth opportunities for promotion

401K with company match

Tuition reimbursement

Flexible work environment

Discretionary PTO(Paid Time Off)

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA / FSA

Telemedicine(Virtual doctor appointments)

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Discount programs

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