Drug Safety Physician
📋 Role Overview & Responsibilities
Our client is looking to fill the role of Drug Safety Physician. This role will be hybrid and based out of the Princeton office.
Responsibilities
Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical study reports, and other similar documents -Experience with single case unblinding -Knowledge with early development activities and documents Contribute to writing and reviewing medical monitoring plans and other plans for clinical trials, internal or between Otsuka Pharmaceutical Development & Commercialization, Inc. and a CRO Serve as the primary medical contact for assigned trial. Provide oversight of medical monitoring activities and medical surveillance activities of CRO Participate in the evaluation and oversight of clinical trial safety surveillance activities Contributes to the review of draft and final clinical trial tables and listings Contributes to the review of draft and final clinical study reports Participates in the analysis of study data and in post-hoc analyses Participates and contributes to the designated product Safety Governance meetings and other routine interactions with OPDC Pharmacovigilance Reviews and contributes to product-wide aggregate report documents, e.g., IB, DSUR, PSURs, annual reports and other similar documents as assigned Performs signaling activities including review of medical/scientific literature, and contribute to safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, and ensure prompt assessment and communication of confirmed safety signals Active contribution to internal and external forums (e.g., DMC, Advisory Boards) Develops and implement Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS) Contributes to product label development, scientific regulatory responses, coding review and approval. Contributes to oversight and provides guidance to medical review of individual case safety reports (ICSRs) for investigational and marketed products Contributes to scientific and medical publications, posters and presentations as needed
Required Qualifications
3-5 Years experience in Drug Safety with Similar Task Must be an MD or DO
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.
Frequently Asked Questions
How do I apply for the Drug Safety Physician position at Solomon Page? ▼
Click the “Apply for this Position” button on this page to submit your application directly to Solomon Page without recruitment intermediary fees.
Is this position eligible for remote work or visa sponsorship? ▼
This position is located in Princeton, NJ with potential relocation and sponsorship assistance depending on candidate qualifications.
Are there any candidate fees on Hirely? ▼
No. Hirely is completely free for candidates. We never charge registration fees or placement fees.
Legitimate employers will never ask you to transfer funds, purchase equipment from unauthorized vendors, or pay application/visa fees. Hirely rigorously monitors listings, but always verify communication is from official corporate email domains.
Learn how to protect yourself against employment fraud →