Job Description

We are seeking an experienced Pharmacovigilance Consultant to provide specialist support in the development, authoring, and maintenance of Risk Management Plans (RMPs) across global markets. This is a flexible, zero-hour contract opportunity suited to an independent consultant with extensive regulatory and pharmacovigilance expertise.

The successful candidate will play a key role in supporting both Marketing Authorisation Applications (MAAs) and post-approval lifecycle activities, ensuring high-quality, compliant RMP documentation aligned with regional regulatory requirements.

Key Responsibilities

• Lead the preparation, authoring, review, and updating of Risk Management Plans (RMPs) for regulatory submissions and post-approval activities.
• Develop RMPs in support of Marketing Authorisation Applications (MAAs) and variations.
• Ensure RMPs comply with regional pharmacovigilance and regulatory requirements.
• Collaborate with cross-functional teams including Regulatory Affairs, Clinical Development, Medical Affairs, Safety, and Quality.
• Provide strategic pharmacovigilance input regarding safety concerns, risk minimisation measures, and pharmacovigilance activities.
• Support responses to health authority questions related to risk management and pharmacovigilance documentation.
• Contribute to the continuous improvement of pharmacovigilance processes and documentation standards.

Requirements

Essential Requirements

• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related discipline.
• Significant experience in pharmacovigilance and drug safety within the pharmaceutical, biotechnology, or consulting sector.
• Demonstrated expertise in authoring and maintaining Risk Management Plans (RMPs).
• Proven experience supporting both:
• Marketing Authorisation Applications (MAAs)
• Post-approval pharmacovigilance activities
• Strong knowledge of global pharmacovigilance regulations and risk management frameworks.
• Experience preparing RMPs for the following markets:
• EU
• Japan
• South Korea
• China
• Brazil
• Excellent scientific writing, communication, and stakeholder management skills.
• Ability to work independently and manage multiple projects within agreed timelines.

Desirable Requirements

• Experience in development of Pre-IND (Investigational New Drug) RMPs.
• Experience with additional regional risk management documentation requirements beyond the specified markets.
• Previous consulting or contractor experience within a global environment.