Senior Scientist, Risk Management & Safety Surveillance

Accountabilities:: Own and coordinate scheduled and ad hoc aggregate safety reports and analyses, ensuring timely and high-quality delivery. Collaborate with therapeutic area safety leaders, Medical Safety Officers, Safety Surveillance Physicians, and other stakeholders to develop safety strategies. Initiate, conduct, and oversee searches of internal and external safety and medical databases. Perform and lead aggregate safety analyses and case-level reviews, interpreting adverse drug reactions and complex safety associations. Author, review, contribute to, and coordinate core safety deliverables and strategic safety documents. Ensure pharmacovigilance commitments, including agreements and assessment reports, are fulfilled. Partner with external vendors to develop and deliver safety reports and related materials. Support Safety Management Teams and participate in assigned product safety activities. Provide guidance on Risk Management Plans, including development, updates, review, and alignment with oversight leads. Lead or support PBRER/PSUR strategies and review safety assessments in collaboration with relevant stakeholders. Support responses to health authority queries by organizing data, reviewing cases and literature, and preparing regulatory comments. Contribute to CCDS and US/EU prescribing information updates as part of label working groups. Lead signal validation and evaluation activities, including assessment of preliminary data and determination of appropriate follow-up. Support Investigator's Brochure safety updates, DSURs, clinical overviews, literature reviews, and Product Safety Strategy updates. Participate in Level 2 escalations and Health Hazard Evaluations, assessing potential safety impact and driving appropriate follow-up. Provide safety input to Clinical Development Teams, Local Working Groups, and other cross-functional meetings. Review regulatory assessor comments and requests and support appropriate responses. Participate in departmental training, cross-functional initiatives, meetings, and knowledge-sharing activities. Identify potential safety issues, escalate concerns appropriately, and reprioritize activities as business and safety needs evolve. Requirements: Bachelor’s degree in Health Science, Biomedical Science, or a related field with 6–8 years of relevant industry experience, or an advanced degree with 4–6 years of relevant experience. Physicians with an MD or equivalent may qualify with approximately 2–5 years of pharmacovigilance or relevant clinical research/Medical Affairs experience. Clinical medicine experience, including at least 3 years of clinical practice, is preferred for physician candidates. Experience in pharmacovigilance, clinical/medical writing, drug safety, or a closely related discipline is preferred. Strong knowledge of drug development principles, benefit-risk assessment, and safety evaluation for both marketed and investigational products. Strong understanding of global pharmacovigilance regulations and safety requirements. Excellent written and verbal English communication skills. Strong analytical capabilities and attention to detail, with the ability to interpret safety data within a broader clinical and regulatory context. Demonstrated ability to understand adverse drug reactions and complex safety associations. Strong organizational and project coordination skills, with the ability to manage multiple deliverables and therapeutic areas. Ability to collaborate effectively across medical, scientific, regulatory, clinical, and external vendor functions. Sound scientific judgment and the ability to identify, investigate, communicate, and escalate potential safety issues. Flexibility and adaptability when priorities change, with the ability to work independently and effectively in a cross-functional environment. Benefits: Base salary range of $80–$115 CAD . Permanent employment opportunity. Flexible and remote-friendly work environment. Fully covered group insurance. Professional development and ongoing training opportunities. Collaborative, quality-focused, cross-functional work environment. Opportunities to contribute to global pharmacovigilance and drug safety initiatives across multiple therapeutic areas.