Senior PV Consultant

I am supporting a CRO who are seeking a contractor to join the team as a Pharmacovigilance consultant manager to support their projects.

This person can be based anywhere in Europe and is a home based position at a minimum of 50% capacity.

Please see below the job description.

Requirement for a Pharmacovigilance Manager:

• Manage and oversee day-to-day pharmacovigilance activities for ongoing clinical trials within our CRO
• Ensure accurate and timely processing of adverse events (AEs), serious adverse events (SAEs), SUSARs, and safety follow-up
• Oversee medical coding (MedDRA, WHO-DD) and data reconciliation with clinical databases
• Review and approve safety case reports prior to submission

Safety Reporting & Regulatory Compliance

• Ensure compliance with applicable regulations and guidelines (ICH-GCP, ICH E2A/E2B/E2F, EU CTR, FDA, MHRA, EMA)
• Manage expedited and periodic safety reporting (SUSARs, DSURs, Development Safety Update Reports)
• Support sponsor safety reporting obligations and ensure CRO responsibilities are met per contracts and SOPs

Quality & Process Management

• Develop, review, and maintain pharmacovigilance SOPs, work instructions, and templates
• Ensure inspection readiness and support regulatory inspections, audits, and sponsor audits

Vendor & Stakeholder Management

• Oversee safety vendors (e.g., safety databases, call centers, medical reviewers)
• Act as primary PV contact for sponsors, investigators, and regulatory authorities
• Collaborate closely with Clinical Operations, Data Management, and Medical Affairs

Leadership & Training

• Provide training and guidance to PV staff and cross-functional teams
• Contribute to the growth and scalability of the CRO's pharmacovigilance function

Qualifications

• Degree in Life Sciences, Pharmacy, Medicine, Nursing, or related field
• Advanced degree preferred
• Minimum 5-8 years experience in pharmacovigilance, including clinical trial safety
• Prior experience in a CRO environment strongly preferred
• Demonstrated experience managing safety reporting and regulatory compliance

Skills & Competencies

• Strong knowledge of global pharmacovigilance regulations and guidelines
• Hands-on experience with safety databases (e.g., Argus, ARISg, SafetyEasy, Oracle Clinical One)
• Excellent organizational and communication skills
• Ability to work independently in a small, fast-paced CRO setting