Medical Director, Pharmacovigilance / Medical Monitor

Position Title: Medical Director - Pharmacovigilance / Medical Monitor

Overview

I am working with a small biotech company seeking an experienced Medical Director to join our team as a Medical Monitor and lead our pharmacovigilance efforts. The ideal candidate will have significant experience in medical monitoring, safety oversight, and critical care, with a strong background in pharmacovigilance.

Key Responsibilities

• Medical Monitoring: Oversee the medical monitoring of ongoing clinical trials, with a focus on safety and efficacy.
• Safety Oversight: Lead the pharmacovigilance activities for our Phase 3 study, ensuring the identification, evaluation, and reporting of adverse events (AEs) and serious adverse events (SAEs).
• Adverse Event Management: Distinguish between complications of cardiac surgery and adverse events, ensuring accurate and timely processing.
• Safety Narratives and Coding: Develop and review safety narratives, ensuring accurate coding using MEDra and WHOdrug classifications. Work on and review coding using Excel.
• Leadership: Provide leadership to the safety team, including mentoring and supervising a safety person reporting to this role.
• Collaboration: Work closely with the Chief Medical Officer and other key stakeholders to ensure the highest standards of patient safety and data integrity.
• Industry Best Practices: Stay current with industry regulations, guidelines, and best practices in pharmacovigilance and clinical safety.

Qualifications

• Medical Degree: MD
• Experience:
• Significant experience in medical monitoring and pharmacovigilance within the biotech or pharmaceutical industry.
• Hands-on experience in a small biotech setting is highly preferred.
• Familiarity with large pharmaceutical companies is acceptable, provided there is a demonstrated ability to navigate and minimize bureaucratic hurdles.
• Technical Skills:
• Proficient in the identification and processing of adverse events.
• Strong understanding of safety narrative writing and coding (MEDra, WHOdrug).
• Experience using Excel for coding and data management.
• Personality Traits:
• Ability to think critically and adapt to fast-paced environments.
• Strong leadership skills with the ability to mentor and supervise junior staff.
• Excellent communication and collaboration skills.

Preferred:

• Specialization in cardiac surgery and/or critical care.

Why Join Us?

• Innovative Environment: Be part of a cutting-edge biotech company where your contributions directly impact patient safety and clinical outcomes.
• Leadership Role: Take on a leadership position with significant influence over our pharmacovigilance processes and safety standards.
• Career Growth: Opportunity for professional growth and development in a supportive and dynamic work environment.

If you are interested in learning more please apply here or send your CV to m.cross@sciproglobal.com