Drug Safety and Medical Information Associate

Job summary

Process and assess pharmacovigilance cases, support aggregate safety evaluations and signal management, and conduct literature reviews while maintaining compliant documentation. Respond to medical information requests, process product complaints, and contribute to response letters, training materials, medical content, and promotional material reviews.

Job details

Duchesnay Inc. is a specialty pharmaceutical company with a strong and ongoing commitment to women's health and rare diseases. The company offers state-of-the-art facilities and a stimulating, safe work environment. Duchesnay Pharmaceutical Group is proud to hold the CONCILIVI Seal, an official recognition of our efforts to support work-life balance for our employees. Drug Safety and Medical Information Associate In this role, the Associate supports pharmacovigilance, drug safety, and medical information activities by ensuring the accurate processing of received information, compliant documentation of activities, and the generation of reliable data for internal teams, partners, and regulatory authorities. Hybrid work model: 1 day per week in the office Key Responsibilities Process adverse event reports in accordance with internal procedures and federal regulations. Participate in the medical assessment of individual pharmacovigilance cases, including coding and follow-up strategy. Contribute to the medical evaluation of aggregate safety reports. Participate in signal management and risk mitigation strategies. Assess whether a foreign regulatory action presents a serious risk relevant to Canada. Conduct and document scientific literature reviews for safety surveillance activities. Respond to information requests from healthcare professionals, consumers, and company representatives. Process and document product complaints. Draft and review medical information response letters. Prepare training materials and content for new product launches. Contribute to medical content development and review promotional materials and websites. Qualifications Healthcare professional preferred, or Bachelor's degree in Health Sciences. Minimum of 2 years of experience in drug safety or pharmacovigilance within the pharmaceutical industry. Ability to work with computerized databases (Argus Safety and/or Scimax-MI considered an asset). Knowledge of MedDRA terminology. Proficiency in Microsoft Office. Oral and written bilingualism (French and English)—due to interactions with national and international partners. Competencies Strong technical and scientific skills in research and data interpretation. Excellent communication and documentation skills. Strong analytical mindset with great attention to detail. Excellent organizational and interpersonal skills. Adaptability and flexibility. We thank all applicants for their interest, but only those who are selected will be contacted.

What you’ll do

Process and assess pharmacovigilance cases, support aggregate safety evaluations and signal management, and conduct literature reviews while maintaining compliant documentation. Respond to medical information requests, process product complaints, and contribute to response letters, training materials, medical content, and promotional material reviews.

Requirements

A healthcare professional is preferred, or a bachelor's degree in Health Sciences, with at least two years of pharmaceutical-industry drug safety or pharmacovigilance experience. Candidates should know MedDRA, be proficient in Microsoft Office, communicate effectively in French and English, and have strong analytical, organizational, scientific, and documentation skills; experience with Argus Safety or Scimax-MI is an asset.

Listed skills

• Microsoft Office · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Pharmacovigilance
• Drug Safety
• Medical Information
• Adverse Event Processing
• Medical Case Assessment
• MedDRA Coding
• Aggregate Safety Report Evaluation
• Signal Management
• Risk Mitigation
• Scientific Literature Review
• Medical Information Response Writing
• Product Complaint Processing
• Promotional Material Review
• Scientific Research
• Data Interpretation
• Microsoft Office

Job areas

• Healthcare
• Science & Research
• Manufacturing