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Our client is a globally recognized Contract Research Organization (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) specializing in Pharmacovigilance (PV) for a remote role within our client’s PV division. You will oversee global clinical projects focusing on pre-marketing phases (Phase I-III), ensuring compliance, risk management, and timely delivery of safety deliverables. This role requires 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 contact for sponsors, investigators, and internal teams (Biometrics, Data Management, Regulatory).
* Pre-Marketing Focus: Lead safety strategies for clinical trials pre-approval, including protocol development, safety monitoring plans, DSURs, and regulatory submissions (e.g., IND/CTA).
* Ensure compliance with ICH-GCP, GVP, FDA/EMA regulations, and client SOPs.
* Risk & Compliance: Identify project risks proactively, implement mitigation plans, and manage audit/inspection readiness.
* Oversee safety database setup (e.g., ARGUS, ARISg) and manage vendors.
* Team & Budget Management: Allocate resources, track budgets and timelines, and ensure projects are delivered on time, within scope, and to quality standards.
Essential Qualifications
* Education: Bachelor’s in Life Sciences, Nursing, Pharmacy, or related field; advanced degrees preferred.
* Experience: 3-5+ years in Pharmacovigilance/Drug Safety within CRO, pharma, or biotech; proven experience managing global pre-marketing clinical projects.
* Expertise in safety activities such as clinical trial safety management, DSMB support, protocol/SAP review, and regulatory filings.
* Skills: Mastery of PV regulations (GVP, ICH E2), safety databases (ARGUS, Veeva), and MedDRA coding; strong communication and stakeholder management skills; ability to work remotely with global teams.
* Certifications: Project management (PMP, PRINCE2) or PV (RAC, CISP) certifications are advantageous.
Additional Details
* Seniority Level: Mid-Senior level
* Employment Type: Contract
* Job Function: Management and Manufacturing
* Industries: Technology, Information, and Internet
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