Patient Safety and Pharmacovigilance Specialist

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

📋 Description

• Perform international adverse event and pharmacovigilance tasks in alignment with regulatory agency standards.

• Coordinate adverse event and pharmacovigilance efforts across global sites.

• Offer support, training, and supervision in drug safety operations, including product quality complaints and medical information services.

• Oversee the pharmacovigilance system and create monthly performance reports.

• Prepare and assess periodic PV metrics, encompassing KPIs, quality incidents, CAPAs, audits, and inspection results.

• Compile and analyze compliance data; conduct root cause evaluations and gap analyses; assess the effectiveness of corrective actions.

• Review safety reports and study documents for thoroughness, accuracy, and clinical significance.

• Assist in audit and inspection readiness, and support internal audits and health authority evaluations.

• Deliver training on adverse event reporting and engage in both internal and external meetings.

• Manage the safety mailbox, evaluate adverse event reports, and coordinate medical assessments and escalations.

• Collaborate with cross-functional teams to improve PV compliance.

• Draft Safety Monitoring Plans and process adverse events within the Argus database.

• Review and submit safety reports to regulatory agencies, address queries, and maintain logs of adverse events.

• Conduct literature reviews for adverse event identification, reconcile AE reports with partners, and oversee product complaints.

• Act as a PV subject matter expert; aid business development, train and supervise staff, and assist with resource onboarding.

⛳️ Requirements

• A Bachelor’s degree in a medical, nursing, pharmaceutical, or life sciences field is required; an advanced degree (e.g., BPharm, PharmD, RN, MD, MSc, or equivalent) is highly preferred.

• Over 3 years of experience in drug safety / pharmacovigilance within the CRO or pharmaceutical sector.

• Experience in Clinical Trials and drug development (phases 1-4).

• Strong verbal and written communication skills.

• Proficient knowledge of the Argus Safety Database.

• Computer literacy and proficiency in Microsoft Office, especially Word, Excel, and PowerPoint.

• Familiarity with FDA regulations and ICH guidance.

• Excellent organizational skills and meticulous attention to detail.

• Ability to thrive in a fast-paced setting and effectively manage shifting priorities.

• Analytical, adaptable, detail-oriented, and quality-focused.

• Resume must be submitted in English.

🏝️ Benefits

• Wellness, growth, and development initiatives.

• Team events and activities that foster employee relationships.

• An inclusive and supportive work environment.

• Reasonable accommodations for qualified individuals with known disabilities.

• A smoke-free, drug-free, and alcohol-free workplace.