SERM Principal Physician

Company Overview

Company details are not specified.

Job Summary

The SERM (Safety Evaluation and Risk Management) Principal Physician is responsible for overseeing pharmacovigilance related activities, ensuring the safety and efficacy of drugs through comprehensive risk management. The role is pivotal in both clinical development and post-marketing phases, contributing to the organization's commitment to patient safety.

Responsibilities

• Oversee the pharmacovigilance process, ensuring effective safety evaluation and risk management.
• Lead activities related to the assessment of drug safety during clinical development and after-market release.
• Maintain up-to-date knowledge of international pharmacovigilance requirements and guidelines.
• Collaborate with cross-functional teams in large matrix organizations to address safety concerns.
• Provide medical expertise and guidance in the preparation of safety reports and regulatory submissions.

Qualifications

• Medical Doctor (MD), veterinarian, or dentist with appropriate pharmacovigilance experience.
• Additional relevant medical or scientific post-graduate qualifications.
• Relevant experience in pharmacovigilance or drug development.
• Knowledge of international pharmacovigilance regulations (e.g., ICH, GVP modules, CIOMS initiatives).
• Experience in clinical development and post-marketing activities.
• Proven ability to work in large matrix organizations and manage complex safety inquiries.

Preferred Skills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Capability of leading cross-functional teams effectively.

Experience

• Experience in pharmacovigilance and drug development is essential, particularly in safety evaluation.

Environment

Work environment details are not specified.

Salary

Salary details are not provided.

Growth Opportunities

Opportunities for career advancement within the organization are not specified.

Benefits

Information on offered benefits is not available.