Pharmacovigilance Consultant – Risk Management Plans

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🎲 Risk

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Quanticate

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Quanticate is a leading global biometric Contract Research Organisation (CRO) specializing in clinical data analysis for the pharma and biotech industries. They provide a range of services focused on enhancing clinical trial efficiency and success, including biostatistics, clinical data management, medical writing, and pharmacovigilance. Quanticate leverages advanced methodologies, such as Bayesian approaches, to optimize trial execution and data standardization, ensuring compliance with regulatory standards. They offer scalable resources tailored to client needs and have expertise across various therapeutic areas and trial phases, from early Phase I to post-marketing Phase IV trials. Quanticate is known for its robust data automation, visualisation, and analytics capabilities, which support decision-making and regulatory submissions.

📋 Description

• 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

• 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.