Senior Scientist, Risk Management – Safety Surveillance

This is a fully remote position, open to applicants in Canada.

📋 Description

• Generate both scheduled and ad hoc aggregate safety reports while serving as the report owner for designated medium-to-large volume, standard-complexity reports.

• Maintain comprehensive product knowledge and assist the Safety Management Team in achieving their objectives.

• Organize activities, lead meetings, search databases, perform aggregate safety analyses and case-level reviews, draft documents, and manage strategic safety initiatives.

• Collaborate with the Therapeutic Area Safety Head, Medical Safety Officers, Safety Surveillance Physician, vendors, and other stakeholders regarding safety strategies.

• Guarantee the timely delivery of high-quality safety reports and analyses.

• Initiate, execute, and supervise both internal and external database searches.

• Author, contribute to, and coordinate essential safety deliverables.

• Ensure compliance with Pharmacovigilance Agreements and commitments related to assessment reports.

• Provide support to the Safety Management Team and lead assigned meetings.

• Oversee the creation and updates of risk management plans.

• Lead or assist with PBRER/PSUR, health authority queries, signal evaluations, DSUR, labeling, literature reviews, Product Safety Strategies, and escalation activities.

• Engage in cross-functional training, departmental meetings, Clinical Development Teams, Local Working Groups, and various other initiatives.

• Identify and escalate potential safety concerns while addressing comments and requests from regulatory assessors.

⛳️ Requirements

• A Bachelor’s degree in Health or Biomedical Science with six to eight years of industry experience or equivalent.

• An advanced degree in Health or Biomedical Science with four to six years of industry experience or equivalent (preferred).

• A Physician (MD or equivalent) typically requires 2–5 years of pharmacovigilance or other pertinent experience.

• At least 3 years of clinical practice experience is preferred for physicians.

• Experience in clinical/medical writing or pharmacovigilance is preferred.

• Excellent English verbal and written communication skills.

• Familiarity with drug development principles, evaluation of drug risks and benefits, safety assessments of marketed and in-development drugs, and global safety regulations is highly preferred.

🏝️ Benefits

• Opportunities for professional development and ongoing training.

• Support for work-life balance.

• A quality-focused, collaborative “one-team” culture.

• Commitment to equal opportunity and inclusive, barrier-free recruitment and selection processes.

• Accommodation for qualified applicants under the Human Rights Code and the Accessibility for Ontarians with Disabilities Act.