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Job Details

Safety Support Specialist

Company: United BioSource Corporation.
Location: Geneva, Switzerland London, United Kingdom
Reference: REQ20011853
Closing Date: 26 Mar 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 expedited reporting to competent authorities, planning and distribution of periodic safety reports, compliance monitoring, liaising with competent authorities to ensure awareness of current regulationsSpecific Job Duties:• Planning and distribution of the periodic safety reports (DSUR, PSUR, 6 monthly line listings) and report ...

Requirements:

Brief Description:

This position is primarily responsible for supporting all operational functions within the Pharmacovigilance Department including, but not limited to expedited reporting to competent authorities, planning and distribution of periodic safety reports, compliance monitoring, liaising with competent authorities to ensure awareness of current regulations

Specific Job Duties:

• Planning and distribution of the periodic safety reports (DSUR, PSUR, 6 monthly line listings) and reporting of SAEs to competent authorities or partners

• Prepare and communicate compliance reports (Monthly, Quarterly and yearly)

• Prepare procedures, SOPs, guidelines and other standard materials required for project

• Coordinate dissemination of specific regulatory intelligence to appropriate individuals

• Record and communicate global regulatory requirements

• Support the preparation of proposals

• Ensure overall compliance with ICH, EMEA and FDA guidelines

Requirements:

• University degree in a science field

• Comprehensive knowledge of ICH and FDA Regulations and Guidelines both clinical and post marketing

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

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

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

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

• Knowledge of database management, electronic reporting tool and use of coding dictionaries, a plus

About UBC

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.

By combining insight from data, understanding patient behavior, and the science behind clinical specialties, we can help our clients make informed decisions and optimize the care given to patients using their therapies and products.

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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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