Associate Director Pharmacovigilance Scientist

Cpl Healthcare; London; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A global pharmaceutical company seeks a Safety Scientist to provide scientific safety oversight across investigational and marketed products. The role involves supporting safety activities, conducting signal detection, and managing safety reports while collaborating with internal teams. Candidates should have experience in clinical and post-marketing risk management. This is a hybrid position with 2 days onsite in North London.

Qualifications

• Direct experience with signal detection and aggregate reports.
• Experience in clinical and post-marketing risk management plans is essential.
• Strong analytical, communication, and collaboration skills.

Responsibilities

• Support safety activities in early and late-phase clinical development.
• Conduct signal detection and contribute to risk-benefit assessments.
• Manage individual case safety reports and prepare aggregate reports.
• Participate in the preparation of regulatory submissions.
• Contribute to the development of safety labeling and core documents.

Skills

Signal detection

Risk management

Strong analytical skills

Communication skills

Collaboration skills

Job description

CPL Life Sciences are in collaboration with a world-renowned global pharmaceutical company who are seeking two new professionals at varying experience levels to join their Safety Science and Pharmacovigilance team. This role provides scientific safety oversight across the full lifecycle of investigational and marketed products.

As a Safety Scientist, you key responsibilities will include:

- Support safety activities in early and late-phase clinical development

- Conduct signal detection, evaluation, and contribute to risk-benefit assessments

- Manage individual case safety reports (ICSRs) and prepare aggregate reports (e.g., DSURs, PBRERs)

- Participate in the preparation and review of regulatory submissions (INDs, NDAs, MAAs, etc.)

- Contribute to the development and maintenance of safety labeling and core safety documents

- Collaborate with internal teams and external partners to ensure high-quality safety deliverables

- Provide safety input to study teams and participate in cross-functional meetings

- Help prepare materials for safety committees (e.g., iDMCs, IMCs) and regulatory authorities

Hybrid: North London 2 days per week on site, 3 days remote

Applicants should have direct experience working with signal detection, aggregate reports and risk management plans in particular for both clinical and post-marketing activities.

Strong analytical, communication, and collaboration skills are essential for success in this role.