Pharmacovigilance Consultant – Risk Management Plans

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee the creation, authorship, evaluation, and revision of Risk Management Plans (RMPs) for regulatory submissions and post-approval tasks.

• Formulate RMPs to support Marketing Authorisation Applications (MAAs) and variations.

• Ensure that RMPs adhere to regional pharmacovigilance and regulatory standards.

• Collaborate with cross-functional teams such as Regulatory Affairs, Clinical Development, Medical Affairs, Safety, and Quality.

• Offer strategic pharmacovigilance insights concerning safety issues, risk mitigation strategies, and pharmacovigilance initiatives.

• Assist in addressing inquiries from health authorities related to risk management and pharmacovigilance documentation.

• Contribute to the ongoing enhancement of pharmacovigilance processes and documentation quality standards.

⛳️ Requirements

• An advanced degree in Life Sciences, Pharmacy, Medicine, or a related field.

• Extensive experience in pharmacovigilance and drug safety within the pharmaceutical, biotechnology, or consulting industries.

• Proven expertise in drafting and managing Risk Management Plans (RMPs).

• Demonstrated experience in supporting both:

• - Marketing Authorisation Applications (MAAs)

• - Post-approval pharmacovigilance activities

• Strong understanding of global pharmacovigilance regulations and risk management frameworks.

• Experience in preparing RMPs for the following markets:

• - EU

• - Japan

• - South Korea

• - China

• - Brazil

• Exceptional scientific writing, communication, and stakeholder management abilities.

• Capability to work autonomously and handle multiple projects within established timelines.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health insurance and wellness programs.

• Opportunities for professional development and continuous learning.

• Flexible working hours and remote work options.

• Collaborative and inclusive work environment.