Senior Scientist, Risk Management – Safety Surveillance

🔥 17 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔒 Insurance

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• Deliver scheduled and ad hoc aggregate safety reports and serve as report owner for assigned medium- to large-volume, standard-complexity reports • Maintain in-depth product knowledge and support Safety Management Team deliverables • Plan and conduct meetings, database searches, aggregate safety analyses, case-level reviews, writing, and project management/coordination of strategic safety documents • Partner with team members, Medical Safety Officers, stakeholders, and vendors • Ensure timely, high-quality reports and safety analyses • Collaborate with the Therapeutic Area Safety Head, Medical Safety Officer, Safety Surveillance Physician, and other stakeholders on strategy development • Initiate, conduct, and oversee internal and external database searches • Perform and/or lead aggregate safety analysis and case-level review • Author, contribute to, and coordinate core safety deliverables • Ensure Pharmacovigilance Agreements and assessment-report commitments are met • Provide Safety Management Team support and lead assigned Safety Management Team meetings • Provide guidance on Risk Management Plan creation and updates • Lead PBRER strategy and review/align approvals for PBRERs, PSURs, DSURs, and other safety documents • Respond to health-authority queries and prepare Marketing Authorization Holder comments • Participate in labeling updates, signal validation and evaluation, Investigator’s Brochure safety-section updates, literature reviews, Product Safety Strategy updates, level 2 escalations, and cross-functional meetings • Recognize and escalate potential safety issues • Review regulatory assessor comments and requests • Participate in cross-functional training, departmental meetings, trainings, and initiatives

🎯 Requirements

• Bachelor’s degree in Health or Biomedical Science and six to eight years of industry experience or equivalent • Alternatively, an advanced degree in Health or Biomedical Science and four to six years of industry experience or equivalent (advanced degree preferred) • Physician (MD or equivalent) generally requires 2–5 years of pharmacovigilance or other relevant experience; demonstrated clinical medicine skills with at least 3 years of clinical practice experience preferred • Strong English verbal and written communication skills • Clinical/medical writing or pharmacovigilance experience preferred • Knowledge of drug development principles, drug risk-benefit assessment, safety assessment of marketed and in-development drugs, and global safety regulations highly preferred

🏖️ Benefits

• Permanent position • Professional development • Excellent work-life balance • Quality-focused, collaborative “one-team” culture • Cross-functional training • Departmental meetings and trainings • Participation in department and/or cross-functional initiatives

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