Director, Safety Surveillance - 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:

• 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

Opportunity Awaits.