18 days old

Medical Assessment Safety Physician

Kelly Services
Lawrence, NJ 08648
  • Jobs Rated
Title: Medical Assessment Safety Physician

Contract: 6 months

Pay: Negotiable

Start Date: 1/14/2021

Work Location: Lawrence Township, NJ 08648

Job Description:

Oversee, Prepare, and/or Review aggregate safety review documents (eg, DSUR, PBRER) and safety sections of relevant clinical trial documents (eg, protocols, clinical study report [CSR], investigator brochure [IB], informed consent form [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]).

Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IRB)/ ethics committee (EC) queries.

Lead the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.

Lead safety activities and benefit-risk strategies for assigned BMS compound(s)/ program and chair the product SMT(s) as required.

Assist the team and senior management in all forms of issue management and crisis management

**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/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at

Jobs Rated Reports for Physician

Posted: 2021-01-01 Expires: 2021-02-01

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Medical Assessment Safety Physician

Kelly Services
Lawrence, NJ 08648

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102nd2019 - Physician
Overall Rating: 102/199
Median Salary: $211,780

Work Environment
Very Poor
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