PV Consultant

Walker Cole International is currently partnered with a Biotech searching for a Freelance Pharmacovigilance Consultant in the United Kingdom for an initial 6-month contract commencing in 2026.

Key Responsibilities:

• Manage and process Individual Case Safety Reports (ICSRs), ensuring timely and compliant submissions to regulatory authorities.
• Ensure adherence to UK MHRA requirements, EU Good Pharmacovigilance Practices (GVP), and ICH guidelines.
• Support signal detection, risk management activities, and aggregate safety reports, including PSURs, DSURs, and RMPs.
• Maintain and contribute to Pharmacovigilance System Master Files (PSMF) and pharmacovigilance documentation.
• Collaborate with cross-functional teams, including Clinical Operations, Medical Affairs, Regulatory Affairs, and Quality Assurance.
• Oversee safety data quality, reconciliation activities, and literature screening.
• Support audits and inspections, ensuring compliance with company SOPs and global regulatory standards.
• Liaise with vendors and partners, supporting Safety Data Exchange Agreements (SDEAs) and PV oversight.
• Provide pharmacovigilance guidance and training to internal stakeholders.

Required Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
• Minimum of 3–5 years of experience in Pharmacovigilance within a biotech, pharmaceutical, or CRO environment.
• Strong knowledge of UK and EU pharmacovigilance regulations, including MHRA, ICH, and GVP guidelines.
• Demonstrated experience in ICSR processing and aggregate safety reporting.
• Familiarity with pharmacovigilance databases such as Argus Safety, ARISg, or Veeva Vault Safety.
• Proficiency in Microsoft Office Suite.
• Excellent attention to detail and strong analytical skills.
• Strong written and verbal communication abilities.

Preferred Qualifications:

• Experience working with early-phase and late-phase clinical development programmes.
• Knowledge of signal detection methodologies and benefit-risk evaluation.
• Experience supporting regulatory inspections and audits.
• Prior experience working within a small or mid-sized biotech environment.
• Understanding of EU Clinical Trial Regulation (CTR) and post-marketing safety requirements.
• Advanced degree or professional certification in Pharmacovigilance or Drug Safety.

Contract Details:

• Start Date: April 2026
• Work Schedule: 5 days per week
• Rate: £50–£70 per hour (dependent on experience level)
• Duration: 6 months (with likely extension)
• Location: United Kingdom – Remote

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