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Pharmacovigilance Clinical Project Lead
Job Posted: 13 hours ago
Salary: £ 50,000 - 55,000 / Annum
Job Type: Permanent
Location: M1, Manchester, Greater Manchester
Expire in: a month
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 plusBefore You Apply
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