Pharmacovigilance Specialist

About Us

At Oracle Life Sciences, we empower life sciences organizations to enhance their offerings that positively impact health and wellness. Our unique combination of consulting expertise, data analytics, and real-world research enables our clients to gain insights into patient, physician, and payer behaviors, facilitating quicker market entry, regulatory navigation, and reimbursement negotiations.

Key Responsibilities

• Identify combinations of inquiries and responses that may indicate a pharmacovigilance event requiring reporting.
• Analyze the pharmacovigilance risks associated with questionnaires directed at healthcare professionals and patients.
• Evaluate the feasibility of studies concerning pharmacovigilance reporting.
• Assist in organizing and delivering pharmacovigilance training sessions for both internal and external stakeholders.
• Implement pharmacovigilance reporting processes for various studies.
• Draft guidelines for interviewers and moderators to ensure timely and accurate event reporting.
• Ensure all follow-up information requests from the Marketing Authorization Holder are addressed promptly.
• Test automated systems to verify the identification of adverse events and pharmacovigilance data from online studies.
• Maintain awareness of project workflows and deadlines.
• Review daily notebooks to identify potential adverse events.
• Complete and submit adverse event forms in compliance with legal requirements and deadlines.
• Coordinate reconciliation and verification of source data related to pharmacovigilance.
• Ensure proper filing and archiving of documents in line with local, global, and European pharmacovigilance regulations.
• Create and manage dashboards for tracking purposes.
• Maintain standard operating procedures for ongoing activities.
• Actively engage in client audits.
• Demonstrate the ability to identify and author Corrective and Preventive Actions (CAPA).
• Note: The candidate will not be responsible for signal detection, writing aggregate reports, or entering Individual Case Safety Reports into safety databases.

Qualifications

• Pharmacy degree or Pharm. D.
• A minimum of one year of experience in pharmacovigilance.
• Fluency in English and French (C1 level); both languages will be utilized daily.
• Exceptional communication skills, capable of clarifying issues, managing client expectations, and acting as a trusted advisor.
• Proficient in multitasking and working under pressure with tight deadlines.
• Strong prioritization skills.
• Excellent organizational abilities and attention to detail.
• Proficient in IT skills, particularly with Microsoft Office Suite.

Career Level

This role involves evaluating internal operations, controls, communications, and risk assessments related to regulatory compliance, with recommendations for improvements. The position also includes conducting internal and external audits to identify and address risks and deficiencies, preparing documentation for regulatory submissions, and managing security and compliance-related projects.