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4 days old

Clinical Drug Safety Scientist

Kelly Services
King of Prussia, PA 19406
**Clinical Safety Scientist**



**King of Prussia, PA**



**1 year contract (extendable)**





**Position Purpose:**



**The Clinical Safety Scientist is an integral member of the Global Clinical Safety and Pharmacovigilance Risk Management function and is a key contributor to the lifecycle risk management activities of products.**


The Clinical Safety Scientist is responsible for conducting integrated safety surveillance, review, analysis of relevant clinical safety data of medicines throughout their lifecycle, that is, for products in clinical development and manufactured products on the market in collaboration with the Clinical Safety Physician.





**Responsibilities:**




+ Support Clinical Safety Physicians in the safety review process and evaluation of safety data throughout the product lifecycle using a combination of quantitative and qualitative approaches

+ Undertake signal detection activities on safety data sets from various sources, such as spontaneous adverse event listings, clinical trial datasets, reports or datasets from observational studies- and present summaries of the data in a meaningful way

+ Review publications from the scientific and medical literature for important safety information; summarize and critically appraise the findings from these publications for safety reports (such as periodic safety update reports, signal detection reports, signal evaluations)

+ Drafting of safety-related documents, particularly sections relating to safety risk management e.g. periodic safety update reports, development safety update reports, clinical overview addenda to support registration activities; and contributing to/ reviewing safety sections of other clinical or regulatory documents including Investigators brochures and submission dossiers

+ Risk Management Activities: Contribute to the production of, and updates to, Risk Management Plans for manufactured products, including drafting of the safety sections.

+ Support ongoing risk management activities by participation in and coordination of the operational and scientific activities associated with internal cross functional Safety Management Teams for the associated products.

+ Participate in associated development teams, such as the Study Execution Team and the Clinical Development Team, in collaboration with the Clinical Safety Physician.

+ Support the physician in providing responses for safety-related questions from internal sources and/or external regulatory requests

+ Contribute to quality improvement: Review, prepare, and/or update local and global SOPs and working instructions as required.





**Qualifications:**




+ Bachelors degree required in the biological, nursing or pharmaceutical sciences. Advanced clinical/scientific degree preferred

+ Understanding of pharmacovigilance and global clinical safety methodology and regulations, guidelines and standards.

+ Strong written and verbal communication skills in English, with the ability to evaluate, interpret and synthesize scientific data.

+ Knowledge and experience of safety monitoring and signal detection preferred.

+ Understanding of ICH GCP and drug development preferred

+ Computer proficiency in basic database entry and graphics presentations (e.g. Microsoft Excel or equivalent).

+ Self-motivated, able to prioritize and plan effectively

+ Ability to work independently and as team player, working in a global cross functional environment




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-11-20 Expires: 2020-12-21

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Clinical Drug Safety Scientist

Kelly Services
King of Prussia, PA 19406

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