Our client is looking for an Associate Director / 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 https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.