Kelly Services Principle Scientist in Marlborough, Massachusetts
Principle Scientist (Pharmacovigilance and Risk Management), Marlborough, MA
Kelly Services is seeking a Principle Scientist for one of our top clients in Marlborough, MA.
Duration: 09/05/2017 – 09/07/2018
Type: Temp to Hire
Hours: 40 hrs/wk, 8am-5pm
In conjunction with Medical Director, perform safety surveillance activities within a product(s) team that include:
Signal Detection and Medical Surveillance Activities - 40 % of Time
Independently evaluates data, identifies opportunities and risks, weighs alternatives and presents analyses to Medical Director for review.
Organize planned and ad hoc safety review activities - Obtain data for signal assessment (e.g., Oracle AERS, FDA AERS data, literature search); generate/request listings, identify cases, prepare initial assessment for review and finalization by Medical Director, follow-up on meeting outcome (as needed), ensure the appropriate maintenance of relevant documentation
Quarterly AE Review of Clinical Trials - Perform first iteration of listings review, discuss issues with Medical Director
Lot Review - Prepare listing and table for Medical Director review and summary Literature Surveillance - Perform review of literature with appropriate documentation; identify case reports as well as new safety information and alert Medical Directors, as appropriate
Risk Management/Post-Approval Commitments . - 10 % of Time
Under supervision of the Medical Director, contribute to creation, annual review and update of RMPs as needed.
Follows up on safety related post-approval regulatory commitments for assigned products
Aggregate Reports - 10 % of Time
Draft/Collect Sections 1 through 8
Work with others to determine topics for discussion in Section 9; prepare first draft of Section 9 for Medical Director review
Follow-up on issues identified in regulatory responses (e.g., assessment reports) US Periodic Reports – Obtain data and develop first draft
Clinical Trial Support - 25 % of Time
Oversee and perform case processing activities working with CTSA to ensure consistency, as needed
Investigator Brochure (IB): Contribute to creation, review and updates of IB Aggregate Reports for investigational products such as DSURs, ASRs, IND Annual - collect, collate, format and draft PVRM data contribution
IND Safety reports - analysis of similar events - Collect, collate, format and draft data contribution and perform first review
Database Lock - Perform reconciliation and signoff
Regulatory - 10 % of Time
Regulatory Requests/Responses - Pull data and draft response in consultation with Medical Director prior to management review
Submissions - Contribute to creation and review of 2.5, 2.7.4 of CTD; Integrated Summary of Safety; proposed labels for submissions
Manage pharmacovigilance related activities associated with proposed safety label changes
Other - 5 % of Time
Effectively manages department workload and product responsibilities.
Manage respective outputs for assigned product(s) ensuring on-time delivery of quality documents. Ensures timely decision-making, problem solving, follow through and appropriate managerial elevation of issues.
Represents functional area on routine issues and facilitates multidisciplinary communications
Master Degree or PhD in Medical Science, Pharmacy or Nursing preferred.
Minimum of 4-6 years in a pharmaceutical organization or related industry with a minimum of 2-3 years pharmaceutical experience in a clinical safety or regulatory affairs departments required.
Minimum of 2-3 years of medical writing experience (Prefer experience in writing pharmaceutical reports such as PSURs, Clinical Study Reports, safety sections of the ISS and/or Common Technical Document, or white paper) and/or experience in Medical Surveillance and Risk Management.
Proven understanding of clinical disease state and implications of treatment.
At ease with data and statistics.
Proven ability to communicate effectively (verbal, presentation at group meetings, etc).
Proven experience with project management (formal or informal).
Strategic thinking, organizational leadership, results-oriented performance, team player.
Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines) and Risk Management.
Excellent interpersonal skills, including ability to work effectively, cross culturally and cross functionally.
Excellent written and verbal communication.
If you are interested in the position, please apply to this posting with an updated resume. Thank you for your time and I look forward to working with you.
Lauren Rogers, Kelly Services Scientific Recruiter
Why Kelly ® ?
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 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
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.
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