Position Summary
Oracle Life Sciences Research Services is seeking a Pharmacovigilance Compliance Expert to support and oversee pharmacovigilance (PV) compliance activities across global research projects. This role is responsible for identifying, documenting, and reporting potential adverse events and product complaints, ensuring compliance with applicable regulatory requirements, client expectations, and internal standard operating procedures.
The ideal candidate is a licensed Pharmacist, fluent in both English and French with pharmacovigilance experience, strong analytical skills, and the ability to work effectively in a fast-paced, client-focused environment.
What You'll Bring
- Commitment to patient safety and regulatory compliance.
- A proactive, quality-focused mindset.
- Strong organizational skills and accountability.
- Ability to work independently while collaborating effectively with global teams.
- A continuous improvement approach to processes, compliance, and operational excellence.
Key Responsibilities
- Assess the pharmacovigilance risk associated with questionnaires administered to healthcare professionals, patients, and other respondents.
- Analyze questionnaires, study materials, and respondent feedback to identify questions, responses, or combinations of responses that may generate reportable pharmacovigilance cases.
- Complete, review, and submit pharmacovigilance forms within established timelines and regulatory requirements.
- Participate in the development and implementation of Corrective and Preventive Actions (CAPAs).
- Support the training and education of colleagues on pharmacovigilance processes, regulations, and best practices.
- Draft and maintain moderator instructions to ensure timely identification and reporting of potential PV cases.
- Monitor and ensure completion of follow-up requests related to reported PV cases.
- Test online studies, surveys, and questionnaires to verify appropriate detection and escalation of potential PV events.
- Review paper diaries and study materials received daily to identify potential adverse events and other reportable safety information.
- Perform pharmacovigilance reconciliations and support data quality activities.
- Participate in data archiving activities and maintain compliance trackers and documentation.
- Maintain and update pharmacovigilance Standard Operating Procedures (SOPs) and related documentation.
- Participate in internal and external audits and support audit readiness activities.
- Collaborate with project teams, quality teams, and clients to ensure compliance with pharmacovigilance requirements.
**Note: **This position does not involve signal detection activities or pharmacovigilance database management.
Qualifications and Requirements
Required Qualifications
- Licensed Pharmacist.
- Minimum of 1 year of experience in pharmacovigilance, drug safety, or a related regulatory compliance function.
- Native-level fluency in French and professional proficiency in English; both languages will be used daily in written and verbal communications.
- Strong understanding of pharmacovigilance regulations, adverse event reporting requirements, and compliance processes.
- Excellent communication and interpersonal skills, with the ability to manage client expectations and serve as a trusted advisor.
- Strong analytical and critical-thinking skills with exceptional attention to detail.
- Ability to prioritize multiple tasks and consistently meet deadlines in a dynamic environment.
- Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook.
Preferred Qualifications
- Experience supporting pharmacovigilance activities in market research, clinical research, healthcare, or life sciences environments.
- Experience participating in audits, inspections, CAPA development, and SOP management.
- Familiarity with global pharmacovigilance regulations and reporting requirements.
- Experience working in a multinational or client-facing environment.
Career Level - IC2