What are the responsibilities and job description for the Director, Safety Surveillance position at Clinical Resource Network (CRN)?
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 :
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.
