Pharmacovigilance Consultant (Risk Management Plans)
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QuanticatePharmaceutical, Biotechnology
United KingdomContractSenior
Salary not disclosed
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Job Details
- Required Skills
- Stakeholder management
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 Marketing Authorisation Applications (MAAs).
- Proven experience supporting post-approval pharmacovigilance activities.
- Strong knowledge of global pharmacovigilance regulations and risk management frameworks.
- Experience preparing RMPs for EU, Japan, South Korea, China, and Brazil markets.
- Excellent scientific writing, communication, and stakeholder management skills.
- Ability to work independently and manage multiple projects within agreed timelines.
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.
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