Associate Director/Director Safety Surveillance

1 month ago


Carlsbad, United States Clinical Resource Network (CRN) Full time

Our client is looking for an Associate Director of Drug Safety Surveillance to join their team remotely.


Responsibilities:


  • Authoring aggregate reports
  • Collaborate with Medical Directors within DSPV
  • Coordinate safety review meetings
  • Signal detection activities; identifying and managing safety signals
  • Develop DSURs, PADERs, IND Annual Reports, PSURs/PBRERs, ad-hoc safety requests from Health Authorities, and other global periodic safety reports
  • Contribute to safety sections of key documents (IBs (including RSI determination), study protocols, ICF, CSRs, CCDS, RMP, REMS)
  • Summarize findings in product safety reports
  • Support safety signal detection and assessment activities
  • Identification and validation of possible trends and concerns related to company and competitor products
  • Perform literature surveillance from published medical literature
  • Review TFLs and AE data to evaluate common AEs and lab abnormalities


Required Qualifications:


  • Minimum Bachelor’s degree
  • Minimum 5 years’ experience in pharmacovigilance in a pharmaceutical or biotechnology company pre- and post-approval pharmacovigilance activities (safety reporting, signal detection activities (safety data analysis, categorization, assessment)
  • US and global experience


If you meet the required qualifications and are interested in this role, please apply today.


Clinical Resource Network Distinction


CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.


About CRN


Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn.


Opportunity Awaits.



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