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Job Details

Safety (pharmacovigilance) Scientist

Company: United BioSource Corporation.
Location: Philadelphia, PA
Reference: REQ20012771
Closing Date: 19 Feb 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Brief Description:This position is primarily responsible for supporting all operational functions within the Pharmacovigilance Department including, but not limited to, client interface and deliverables, individual case safety report (ICSR) case processing and reporting; assisting with project start-up: process flows; assist with database configuration needs; support preparation and quality control of safety aggregate reports; training, mentoring and contributing to the development and maint ...

Requirements:

Brief Description:

This position is primarily responsible for supporting all operational functions within the Pharmacovigilance Department including, but not limited to, client interface and deliverables, individual case safety report (ICSR) case processing and reporting; assisting with project start-up: process flows; assist with database configuration needs; support preparation and quality control of safety aggregate reports; training, mentoring and contributing to the development and maintenance of departmental standards (SOPs) and guidelines.

 

ESSENTIAL FUNCTIONS

•  Assist with the preparation of adverse event reporting plans (AERPs) and other plans as required

•  Review project specific proposals, pricing and protocols to ensure consistency within the AERP

•  Maintain a listing of all administrative changes and updates

•  Ensure all processes’ as described are operational

•  Alert Project Management when activities fall outside SOW

•  Participate in change order generation

•  Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality and expectedness assessment

•  Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings

•  Actively engage in gap analysis for SOPs and guidance documents

•  Preparation of training materials specific to safety, participate and/or lead training sessions.

•  Assist in the reconciliation of clinical and safety databases.

•  Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment

•  Perform literature review for identification of case reports and other relevant safety information

•  Collaborate with Senior Management to update or design project process improvements

•  Liaise with both internal and external vendors (clients, patients and HCPs)

•  Review/Quality Check (QC) of source documents, coding, data entry, report generation and distribution

•  Monitor compliance metrics and ensure appropriate documentation when deficient.

•  Assist in evaluation and validation of systems to support safety.

•  Other duties as assigned by management

 

QUALIFICATIONS

•Registered Nurse, Pharmacist, or other degree in a science-related field

•Knowledge of ICH, EMA and FDA Regulations and Guidelines both clinical and post marketing

•Prior experience in CRO/Pharma/Biotech safety department minimum 3 years

•Knowledge of vaccine and medical device reporting requirements, a plus

•Proficient with case review, extrapolation and composition of ICSR narratives and causality assessment

•Proficient with computer programs (Safety database, Word, PowerPoint, Excel)

•Knowledge of database management and use of coding dictionaries

•Good communication, interpersonal interaction, project management and organizational skills are essential

•Fluent in English, additional language fluency a plus, but not required

•Ability to multitask with exceptional time management skills

 

ABOUT UBC

United BioSource Corporation (UBC) is the leading provider of integrated pharmaceutical support services that optimize global product safety, brand loyalty and patient access on behalf of our manufacturer clients.

 *LI-CD1-UBC

Apply for this job: Safety (pharmacovigilance) Scientist

Contact Information:

Address:  United BioSource Corporation (UBC)
Europe Headquarters
26-28 Hammersmith Grove
London
United Kingdom
W6 7HA
England
Tel:  +44 (0)20 8834 0100
Website:  Visit Our Web Site

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