Safety Lead / United Kingdom

JR United Kingdom; City of Edinburgh; On-site; GBP 40,000 - 65,000; Full time

Job summary

A leading company in pharmacovigilance is seeking a Safety Lead to ensure compliance with regulations and manage PV activities. Responsibilities include overseeing local PV operations, supporting audits, and advising on PV impact of programs. This role requires strong analytical and communication skills, along with relevant experience in the pharmaceutical industry.

Qualifications

• Bachelor’s Degree in Health Care Science required, preferably as Physician or Pharmacist.
• 6-8 years experience in safety and pharmacovigilance preferred.

Responsibilities

• Manage daily PV operations and regulatory compliance.
• Oversee and coach local PV staff or vendors.
• Lead audits and ensure local safety process management.

Skills

Analytical skills

Problem-solving skills

Organizational abilities

Communication skills

Negotiation skills

Education

Bachelor’s Degree in Health Care Science

Tools

IT safety systems

Job description

The Safety Lead is responsible for ensuring that all pharmacovigilance (PV) activities within the Local Operating Company (LOC) comply with local regulations and company policies at local, regional, and global levels. This includes oversight of activities aligned with product vigilance agreements (PVAs) with third-party partners. The Safety Lead may serve as the primary PV contact for the local health authority and is accountable for establishing and maintaining effective PV and risk management systems across assigned territories.

Key Responsibilities:

1. Ensuring daily PV operations and regulatory compliance at the local level.
2. Acting as delegate for the Regional Safety Head when needed.
3. Overseeing and coaching local PV staff or vendors.
4. Supporting inspection readiness and leading audits/inspections locally.
5. Managing local safety processes, PSMF input, AE reporting, and CAPA development.
6. Advising local business on PV impact of programs and regulatory changes.
7. Ensuring local implementation of global PV procedures and training.
8. Monitoring changes in local PV legislation and ensuring compliance.

Role Qualifications:

• A minimum of a Bachelor’s Degree in Health Care Science (preferably Physician or Pharmacist).
• Preferably 6-8 years of relevant experience in safety and pharmacovigilance within the pharmaceutical or Contract Research Organization (CRO) industry.
• Excellent verbal and written communication skills in the local language and English.
• Computer literate with knowledge of relevant IT safety systems.
• Based in High Wycombe / United Kingdom.

Expected Skills:

• Strong analytical and problem-solving skills, with high attention to detail.
• Excellent organizational abilities; capable of managing multiple priorities effectively.
• In-depth understanding of pharmacovigilance, drug development, and pharmacology principles.
• Proven experience in line management and vendor oversight.
• Expert knowledge of relevant global, regional, and local PV procedures.
• Strong communication and negotiation skills with both internal and external stakeholders.
• Ability to build and maintain effective relationships with regulatory authorities and cross-functional teams.
• Solid understanding of local and global product safety requirements.

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Created on 04/06/2025 by JR United Kingdom