Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Safety Scientist

Company: United BioSource Corporation.
Location: Philadelphia, PA Philadelphia, PA
Reference: REQ20012060
Closing Date: 21 Mar 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

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

Requirements:

Brief Description:

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

Requirements:

  • Registered Nurse, Pharmacist, or other health care professional degree
  • Comprehensive knowledge of ICH and FDA Regulations and Guidelines both clinical and post marketing
  • Knowledge of vaccine and medical device reporting requirements, a plus
  • 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

Supervisory Responsibilities:

  • Ensure time management and assess quality of work
  • Able to provide constructive feedback for performance improvement when appropriate.

Specific Job Duties:

  • Assist with the preparation of adverse event reporting plans (AERPs)
  • Maintain a listing of all administrative changes and updates
  • Ensure all processes as described are operational
  • Alert Project Management when activities fall outside SOW
  • Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality 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
  • Assist in the reconciliation of clinical and safety databases.
  • Liaise with both internal and external vendors (clients, patients and HCPs)
  • Medical review 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.

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.

*LI-CD1-UBC

Apply for this job: Safety 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

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.