Kelly Services Safety Analytics Scientist -Global Drug Safety Risk Management in Cambridge, Massachusetts
Kelly Services is seeking a Safety Analytics Scientist / Global Drug Safety Risk Management Lead t o one of our top clients in Cambridge, MA for a W2 contract through March of 2019.
The Global Drug Safety Risk GDS Management Lead is the drug safety expert for assigned products; maintains current knowledge of assigned product portfolio and safety profiles for products.
He/she is responsible for safety risk assessment, management, minimization and communication for assigned development and marketed products.
He/she is also provides input into and review of aggregate reports and safety documents, including labeling changes.
Responsibilities Responsible for the implementation of benefit-risk management for Company products.
Development of REMS, DRMPs RMPs, regulatory responses for risk management topics and other product position statements as assigned for submission to regulatory agencies.
Actively participates in Benefit- Risk Committees and other safety committees as needed.
Effectively manages the Benefit/Risk process.
Prepares and assists in the management of Risk Management project timelines.
Ensure all risk management documents are prepared according to regulatory requirements, facilitate review and sign-off.
Ensure all regulatory commitments in RMPs are followed tracked.
Represent Risk Management on cross functional teams and Interface with other Company functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed.
Communicates effectively on product risks to Risk Management Team Lead. Provide advice and liaises with the Global Safety Leads that improve the consistency and accuracy of Benefit Risk assessment.
Critically review provide medical/safety input of PBRER, RMP, DSUR, Clinical Expert statement, Regulatory responses, IB, NDA Submissions, MAA Submission ad hoc reports.
Ensures that the safety risks with Company projects/products are identified promptly Represent GDS- Risk Management for internal and external Risk Management forums as safety and risk management experts, including regulatory agency meetings such as EMA, FDA as needed.
Contribute to on-going process enhancement for safety surveillance such as developing standard procedures and templates.
Participate in other activities, teams and committees as assigned.
Education and experience requirements :
MD, PhD, Pharm D, or Masters degree in a science or healthcare related discipline with specialty training in functional area and at least 2 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products.
At least 1 year of experience writing and preparing risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies or commensurate experience.
Key skills, abilities, and competencies:
Previous experience in bioscience preferred. Ability to read and analyze scientific and medical literature. Ability to work with interdisciplinary, highly matrixed team.
Knowledge and active use of Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat Analytical and problem solving skills. Oral and written communication and interpersonal skills.
Planning and Organizing Ability to manage multiple projects simultaneously while remaining responsive to strict deadlines. Ability to establish and maintain professional communication both internally and externally with all stakeholders.
With Kelly®, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 99 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group- rate insurance options available immediately upon hire*
For immediate consideration if you meet the requirements above, please email your CV to firstname.lastname@example.org or click "apply now"
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place.
Let Kelly fuel your career—connect with us today.
*Available for purchase and administered by a designated third-party vendor
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, and Gender Identity, and is committed to employing a diverse workforce.
Why Kelly ® ?
At Kelly Services ® , we work with the best. Our clients include 95 of the Fortune 100 ™ companies, and more than 70,000 hiring managers rely on Kelly annually to access the best talent to drive their business forward. If you only make one career connection today, connect with Kelly.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm