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Job Details

UBC - Safety Submissions Specialist

Company: United BioSource Corporation.
Location: Geneva, Switzerland; London, United Kingdom
Reference: 1600003T
Closing Date: 10 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Comprehensive Package

Job Summary:

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

Requirements:

Since 2003, UBC has been the home for people who are passionate about innovation, service and making a difference in peoples' lives and in the healthcare and biotech industries. As a service organization, UBC employees are our greatest resources. Their skills and expertise are what sets us apart in the industry.

Working here, you will support the development of life-changing therapies. You will work with peers who will become friends and leaders who listen to your feedback in a collaborative, innovative and fast-paced culture. You will enjoy competitive benefits, pay-for-performance compensation and rewarding recognition that promotes internal quality and critical alignment of our business objectives. And finally, you will enjoy the vast network of resources of our Fortune 20 parent organization, Express Scripts.


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:
•Ensure timely reporting of SAEs to competent authorities or partners
•Ensure planning and distribution of the periodic safety reports (DSUR, PSUR, 6 monthly line listings…)
•Monitor compliance metrics and ensure appropriate documentation when deficient
•Prepare and communicate compliance reports (Monthly, Quarterly and yearly)
•Prepare procedures, SOPs, guidelines and other standard materials required for project
•Participate in Quality Check activities
•Maintain  an in-depth knowledge of the relevant drug safety software and related systems
•Attend, participate to team meetings
•Keep informed about the relevant regulations, legislation
•Coordinate dissemination of specific regulatory intelligence to appropriate individuals
•Record and communicate global regulatory requirements
•Support the preparation of proposals
•Participate in relevant seminars and congresses
•Ensure overall compliance with ICH, EMEA and FDA guidelines
•Other duties as assigned by management
 
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
•Good presentation and training skills
•Fluent in English, additional language fluency a plus, but not required
•Ability to multitask with exceptional time management skills
•Knowledge of vaccine and medical device reporting requirements, a plus
•Knowledge of database management, electronic reporting tool and use of coding dictionaries, a plus
 

*LI-AF1-UBC
NO AGENCIES PLEASE

Apply for this job: UBC - Safety Submissions Specialist

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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