MJ
Molly James
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Work Experience
2015 - Present · 9 years and 11 months
President
2017 - Present · 7 years and 11 months
Vice President, Global Safety Operations
2015 - 2017 · 2 years
Five Oaks Pharm, LLC
President
2011 - 2015 · 4 years
Company Details
Drug Safety Navigator LLC (DSN) helps companies navigate the complexities of drug safety compliance. We support small to medium-sized pharmaceutical companies, biotech firms and CRO's at various stages of drug or medical product development. DSN works both on a project basis as well as serving as a full virtual safety department for our clients. Our services include Adverse Event Reporting, Regulatory Inspection preparation, Safety Signal Reporting. We also offer support for Individual Case Safety Reporting, Medical Writing & Monitoring, and Adverse Event Coding (MedDRA, WHO Drug, etc.) Our mission is to provide continuous innovation, outstanding quality, and cost-effective solutions that will maintain regulatory compliance and promote patient safety.
Year Founded
2011
Social Media
LinkedinFacebookTwitter
Industry
Pharmaceutical Manufacturing, Writing & Publishing
HQ Location
2 Davis Drive #156 Research Triangle Park, NC 27709, US
Keywords
Drug Safety and Pharmacovigilance TrainingMedical ConsultingClinical and Post Marketing Medical WritingRegulatory Inspection and PreparednessData ManagementAdverse Event CodingRegulatory Inspection PrepSafety Signal DetectioAdverse Event Reporting
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Contact Details
  • Email AddressM**@drugsafetynavigator.com
    Reveal Email
  • Phone Number(xxx)xxx-xxxx
    Reveal Phone

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