At a Glance
- Tasks: Lead the development and maintenance of Risk Management Plans for global markets.
- Company: Join a leading pharmaceutical consultancy with a focus on drug safety.
- Benefits: Flexible zero-hour contract, work remotely, and gain valuable experience.
- Other info: Opportunity to collaborate with cross-functional teams and improve industry standards.
- Why this job: Make a real impact in pharmacovigilance and enhance your expertise in a dynamic field.
- Qualifications: Advanced degree in Life Sciences and significant pharmacovigilance experience required.
The predicted salary is between 50 - 70 £ per hour.
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) and 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.
Pharmacovigilance Consultant (Risk Management Plans) - Zero-Hour Contractor United Kingdom Phar[...] employer: QUANTICATE INTERNATIONAL LIMITED
As a Pharmacovigilance Consultant with us, you will enjoy the flexibility of a zero-hour contract while contributing to critical global health initiatives. Our supportive work culture fosters collaboration across diverse teams, providing ample opportunities for professional growth and development in the dynamic field of pharmacovigilance. Join us to make a meaningful impact in drug safety and regulatory compliance, all while enjoying the autonomy that comes with independent consultancy.
Contact Details:
QUANTICATE INTERNATIONAL LIMITED Recruitment Team
