Pharmacovigilance Consultant - SOP Writing Contract Opportunity | Leading CRO | Remote/Flexible We are seeking an experienced Pharmacovigilance (PV) Consultant to support a leading Contract Research Organization (CRO) in developing and refining Standard Operating Procedures (SOPs) related to pharmacovigilance operations. This consulting assignment is ideal for a PV expert with a strong background in regulatory compliance, process optimization, and technical writing. Key Responsibilities: Develop, review, and refine pharmacovigilance SOPs in alignment with global regulatory requirements (e.g., FDA, EMA, MHRA, ICH). Collaborate with cross-functional teams to ensure SOPs align with operational workflows and industry best practices. Provide strategic input on PV process improvements to enhance compliance and efficiency. Ensure consistency, clarity, and regulatory compliance in all documentation. Support training initiatives by providing clear guidance on new and revised SOPs. Stay updated on evolving PV regulations and translate changes into SOP updates. Key Requirements: Extensive experience in pharmacovigilance, regulatory compliance, and PV process development. Proven expertise in SOP writing within a CRO, pharmaceutical, or biotech environment. Strong knowledge of global pharmacovigilance regulations (ICH, GVP, FDA, EMA). Excellent technical writing, communication, and stakeholder engagement skills. Ability to work independently and meet project deadlines effectively. Assignment Details: Start Date: April Duration: 3 months Location: Remote, Europe Engagement Type: Contract/Consulting If you are a seasoned pharmacovigilance professional with a passion for optimizing regulatory processes, we'd love to hear from you. BioTalent
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