Senior Drug Safety Scientist

Key People

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Job ID :

15326


Company Type :

Staffing Firms


Industry :

Science and Research


Education Level :

Bsc


Address 1 :

United Kingdom,--St.Albans,St. Albans,


Key Skills :

drug safety, scientist, safety, DS, PV


Salary :

£30 - £35 per hour


Date Posted :

25 Sep, 2019



Company Name :

Key People


Location1 :

St. Albans




Job Category :

Drug Safety Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

The Senior Safety Scientist supports early and late phase development activities as a member of the safety team under the leadership of the Safety Science Leader (SSL) providing essential safety oversight and input into all aspects of study management across the entire development portfolio. In the post-market setting, this role contributes to safety science deliverables required to maintain license to operate and to manage and communicate the evolving safety profile.

Job Responsibilities:

●Represent Safety Science with business process owners on processes executed by Safety Science
●Responsible for coordination and collaboration with vendors servicing Safety Science
●Acts independently to manage safety responsibilities on study teams and in activities supporting safety science
●Trains and mentors more junior members of the safety team
●Takes on responsibility for more complex deliverables
●Takes on team leadership responsibility in order to manage and complete projects requiring more coordination and insight for low-medium priority projects
●Understands how safety activities contribute to development goals and takes measures to maximize safety value to the organization
●Takes on speaking opportunities and team leadership opportunities
●Demonstrates independence and high competence in the conduct of all safety science responsibilities
●Demonstrates behaviors consistent with company values and engenders confidence from senior management
●Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER
●Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance, and drug safety reports.
●Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS
●Contributing to study management through SMT/PET and document review across the development continuum (early phase to post marketing studies), including PASS
●Interfacing with business process owners on processes executed by Safety Science
●Coordinate and assist in responding to Health Authority requests
●Responsible for supporting processes involving safety science such as the expected terms list, MedDRA baskets, ICF process, etc.
●Supporting product quality issues
●Responsible for carrying out activities related to quality system management for safety science

Experience Required:

●Work experience in pharma safety, pharmacovigilance or other related pharmaceutical development area
●Understanding of GxP and regulated processes and end to end clinical trial lifecycle
●Strong orientation towards process improvement and cross-functional teamwork
●Effectively work with remote partners on a global team
●Excellent communication skills, both written and verbal
●Perform application of data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
●(For roles in China) Fluent in Mandarin and English

For further details about this role, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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