O pozici
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.
Co budeš dělat
- 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.
