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

Responsibilities:

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

  • PSURs

  • 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

Experience/Requirements:

  • 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

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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