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.