Job Description

About Our Client

Our client is a globally recognised Contract Research Organisation (CRO) specializing in end-to-end drug development services. They partner with leading pharmaceutical and biotech companies to deliver innovative solutions in clinical research and pharmacovigilance (PV).

Role Summary

Qualitas is recruiting a

Clinical Project Lead (CPL)

specialising in

Pharmacovigilance (PV)

for a remote role within our client's PV division. You will oversee global clinical projects with a focus on

pre-marketing phases

(Phase I-III trials), ensuring compliance, risk management, and timely delivery of safety deliverables. This role demands strong project oversight and PV expertise.

Key Responsibilities

Project Leadership

: Manage end-to-end PV activities for assigned clinical projects (including ICSR processing, SAE/SUSAR reporting, signal detection, and risk management plans). Serve as the primary PV point of contact for sponsors, investigators, and internal teams (Biometrics, Data Management, Regulatory).

Pre-Marketing Focus

: Lead safety strategy for clinical trials pre-approval, including protocol development, safety monitoring plans, DSURs, and regulatory submissions (e.g., IND/CTA). Ensure alignment with ICH-GCP, GVP, FDA/EMA regulations, and client SOPs.

Risk & Compliance

: Proactively identify project risks, implement mitigation plans, and manage audit/inspection readiness. Oversight of safety database setup (e.g., ARGUS, ARISg) and vendor management.

Team & Budget Management

: Allocate resources, and track project budgets/timelines. Deliver projects on time, within scope, and to quality standards.

Essential Qualifications

Education

: Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field. Advanced degree (MS, PhD, PharmD) preferred.

Experience

: 3-5+ years in

Pharmacovigilance/Drug Safety

within a

CRO

, pharmaceutical company, or biotech.

Proven track record managing global clinical projects in pre-marketing phases

(Phase I-III). Expertise in pre-approval safety activities: clinical trial safety management, DSMB support, protocol/SAP review, and regulatory filings.

Skills

: Mastery of PV regulations (GVP, ICH E2), safety databases (e.g., ARGUS, Veeva), and MedDRA coding. Strong communication, and stakeholder management skills. Ability to work remotely with global teams across time zones.

Certifications

: Project management (PMP, PRINCE2) or PV (RAC, CISP) certifications are a plus.
Job Types: Full-time, Permanent

Pay: 50,000.00-55,000.00 per year

Benefits:

Work from home
Schedule:

8 hour shift Monday to Friday
Experience:

Pharmacovigilance : 3 years (preferred) Pre-marketing PV: 3 years (preferred)
Work authorisation:

* United Kingdom (required)