JobWatch

17 days old

Medical Director, Drug Safety

Kelly Services
South San Francisco, CA 94080
Kelly is working with a leading pharmaceutical company in South San Francisco seeking a talented Medical Director, Drug Safety. This is a permanent opportunity.



What you will do:




+ Set and execute the department strategy and day to day functions of the Drug Safety department.

+ Ensure safety reports are processed and reported according to ICH-GCP guidelines and company SOPs

+ Perform QC review of cases for accuracy and completeness of information

+ Work collaboratively with various departments and lead clinical data review meetings

+ Oversee communication with vendors, sponsors, CROs, and other partner companies

+ In charge of developing safety projects

+ Main point of contact for investigational product complaints

+ Review safety sections of IBs, CSRs, ISS, & NDAs

+ Oversee the process of new vendor selection

+ Negotiation of PVAs

+ Prepare all reports

+ Manage and oversee budget

+ Ensure proper training of all employees and outside vendors

+ Reconciliation of safety data with external groups

+ Monitor and adjust company policies according to global safety guidelines



Qualifications:




+ Degree requirement: Must have an M.D.

+ At least 10 years of drug safety and clinical research experience in pharmaceutical industry

+ Global experience with drug safety is preferred

+ Oncology Therapeutic Area experience preferred

+ Thorough understanding of FDA, EU, and ICH guidelines

+ Post market and clinical trial safety experience

+ Travel will be required



To schedule a time to go over the position in more detail and for immediate consideration follow the link to schedule a time to connect: https://calendly.com/staceynakagawa/30min




**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.

Categories

Posted: 2020-09-04 Expires: 2020-10-05

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Medical Director, Drug Safety

Kelly Services
South San Francisco, CA 94080

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast