Pharmacovigilance Analyst in Canada Creek, Nova Scotia at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Pharmacovigilance Analyst based in Canada.

This is an opportunity to contribute to patient and product safety within a global healthcare environment.
You’ll play a hands-on role in identifying, assessing, documenting, and reporting safety information across pharmaceutical and medical products.
The position covers the full lifecycle of individual case safety reports, from initial triage and data entry through medical evaluation and regulatory reporting.
You’ll also contribute to literature reviews, aggregate safety reports, signal detection, and risk management activities.
The role involves close collaboration with internal teams, clients, and external stakeholders to ensure accurate and timely safety information.
You’ll work within established procedures and regulatory standards while supporting audit readiness and continuous compliance.
This position is well suited to a detail-oriented professional who wants to make a meaningful contribution to healthcare safety and regulatory excellence.

• Identify and assess Adverse Events (AEs), Adverse Drug Reactions (ADRs), Adverse Drug Experiences (ADEs), and Medical Device Incidents (MDIs) from source documentation.
• Process Individual Case Safety Reports (ICSRs) in accordance with applicable SOPs and Work Instructions, including triage, duplicate searches, data entry, MedDRA coding, narrative writing, medical evaluation, seriousness, expectedness, causality, and reportability assessments.
• Manage expedited and periodic safety submissions in accordance with applicable regulatory requirements and internal procedures.
• Conduct literature reviews to identify relevant safety information and ensure appropriate documentation and follow-up.
• Prepare and/or review aggregate safety reports, including Annual Summary Reports, Issue-Related Summary Reports, PSURs, PBRERs, PADERs, and DSURs.
• Perform signal detection activities and support the identification and assessment of emerging safety concerns.
• Prepare and/or update Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and related documentation.
• Serve as a point of contact for clients and collaborate with internal and external stakeholders to obtain additional information or clarification when required.
• Support audit preparation and maintain accurate, complete, and properly organized safety documentation in accordance with applicable procedures.
• Take on additional pharmacovigilance activities as assigned by management and participate in standby or on-call responsibilities when required.

• Bachelor’s degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related discipline, or equivalent relevant experience.
• At least 2 years of experience in pharmacovigilance, regulatory affairs, quality assurance, compliance, documentation control, or a closely related field.
• Strong understanding of safety case processing and the principles involved in adverse event and adverse drug reaction assessment.
• Familiarity with pharmacovigilance processes such as ICSR management, MedDRA coding, medical evaluation, causality and seriousness assessment, signal detection, and regulatory reporting.
• Ability to work accurately with detailed safety and regulatory documentation while following established SOPs and Work Instructions.
• Strong analytical and organizational skills, with the ability to prioritize multiple tasks and meet required timelines.
• Effective written and verbal communication skills, with the confidence to collaborate with clients and stakeholders and request clarification when needed.
• Strong attention to detail and a commitment to data accuracy, compliance, confidentiality, and patient safety.
• Ability to work independently while contributing effectively within a collaborative, multidisciplinary environment.
• Certification in regulatory affairs, quality management, compliance, or auditing is preferred.

• Salary: CAD $55,002–$109,901, depending on qualifications, experience, and other applicable factors.
• Healthcare: Medical, dental, and vision benefits.
• Well-being: Resources and programs supporting physical, emotional, financial, and social wellness.
• Family support: Benefits may include backup dependent care, adoption assistance, family-building support, infertility coverage, paid parental leave, and paid caregiver leave.
• Professional development: Training programs, professional development resources, and mentorship opportunities.
• Community and inclusion: Opportunities to participate in employee resource groups and volunteer activities.
• Work environment: A highly inclusive culture focused on helping employees build meaningful careers and contribute to better health outcomes.
• Additional resources: A broad range of employee programs and benefits designed to support different stages of personal and professional life.