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: Vernier, Geneva, Switzerland,London, United Kingdom
Reference: REQ20008311
Closing Date: 20 Dec 17
Type: Full Time
Salary (£): Competitive
Benefits: Comprehensive Package

Job Summary:

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, project start-up, database configuration, literature review, training and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines.

Requirements:

Brief Description:

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, project start-up, database configuration, literature review, training and contributing to the development and maintenance of departmental Standard Operating Procedures (SOPs) and guidelines. 

Specific Job Duties:

• Writing of procedural documents such as Adverse Event Reporting Plans (AERPs)

• Adverse Event case processing: receipt, data entry, coding, and evaluation of Adverse Event reports according to the applicable SOPs, including writing the narrative; perform seriousness, listedness 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

• Monitor compliance and ensure appropriate documentation (metrics, deviations)

• Assist in evaluation and validation of systems to support safety e.g. supporting the development teams in safety database configuration and EDC specifications

• Performing global and local literature review

• Project oversight and identification of issues. Escalation.

Requirements:

• Registered Nurse, Pharmacist, or other Life - Science degree

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

• Experience in pre and post marketing Pharmacovigilance

• Experience in literature review

• Experience in case processing and PV regulatory reporting activities

• Experience in data entry in ICH E2B compliant database

• Knowledge of database management a plus

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

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.

 

UBC’s services include Clinical Development & Late Stage Research, Risk Management & Pharmacovigilance, Reimbursement & Patient Assistance, Nursing & Adherence and Product Access & Channel Management.  UBC works hand-in-hand with Accredo and CuraScript SD to contract with manufacturers for specialty pharmacy and distribution services.

 

ABOUT EXPRESS SCRIPTS

Advance your career with the company that makes it easier for people to choose better health. Express Scripts is a leading healthcare company serving tens of millions of consumers. We are looking for individuals who are passionate, creative and committed to creating systems and service solutions that promote better health outcomes. Join the company that Fortune magazine ranked as one of the "Most Admired Companies" in the pharmacy category. Then, use your intelligence, creativity, integrity and hard work to help us enhance our products and services. We offer a highly competitive base salary and a comprehensive benefits program, including medical, prescription drug, dental, vision, 401(k) with company match, life insurance, paid time off, tuition assistance and an employee stock purchase plan.

 

Express Scripts is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, national origin, age, veteran status, disability, or any other protected class. Applicants must be able to pass a drug test and background investigation. Express Scripts is a VEVRAA Federal Contractor.

*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.