Pharmacovigilance Consultant (Risk Management Plans) - Zero-Hour Contractor

About the role

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. 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.