Senior Scientist, Risk Management – Safety Surveillance

🔥 13 hours ago

🇨🇦 Canada – Remote

💵 $80 - $115 / hour

⏰ Full Time

🟠 Senior

🔒 Insurance

👻 Ghost score 0%

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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 act as report owner for assigned medium-to-large volume, standard-complexity reports • Maintain in-depth product knowledge and support Safety Management Team deliverables • Plan activities, conduct meetings, search databases, perform aggregate safety analysis and case-level review, write documents, and coordinate strategic safety projects • Collaborate with Therapeutic Area Safety Head, Medical Safety Officers, Safety Surveillance Physician, vendors, and other stakeholders on safety strategy • Ensure timely, high-quality safety reports and analyses • Initiate, conduct, and oversee internal and external database searches • 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 meetings • Guide risk management plan creation and updates • Lead or support PBRER/PSUR, health-authority query, signal evaluation, DSUR, labeling, literature-review, Product Safety Strategy, and escalation activities • Participate in cross-functional training, departmental meetings, Clinical Development Teams, Local Working Groups, and other initiatives • Recognize and escalate potential safety issues and address regulatory assessor comments and requests

🎯 Requirements

• Bachelor’s degree in Health or Biomedical Science and six to eight years of industry experience or equivalent • Advanced degree in Health or Biomedical Science and four to six years of industry experience or equivalent (preferred) • Physician (MD or equivalent) generally requires 2–5 years of pharmacovigilance or other relevant experience • At least 3 years of clinical practice experience for physicians (preferred) • Clinical/medical writing or pharmacovigilance experience (preferred) • Strong English verbal and written communication skills • Knowledge of drug development principles, assessment of drug risks and benefits, safety assessment of marketed and in-development drugs, and global safety regulations (highly preferred)

🏖️ Benefits

• Professional development and continuous training • Work-life balance • Quality-focused, collaborative “one-team” culture • Equal opportunity and inclusive, barrier-free recruitment and selection processes • Accommodation for qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act

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