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- Tasks: Lead global clinical projects in pharmacovigilance, ensuring compliance and timely safety deliverables.
- Company: Join a top-tier CRO known for innovative drug development solutions.
- Benefits: Enjoy remote work flexibility and opportunities for professional growth.
- Why this job: Make a real impact in drug safety while collaborating with global teams.
- Qualifications: Bachelor's degree in Life Sciences; 3-5+ years in pharmacovigilance required.
- Other info: Project management certifications are a plus; work across time zones.
The predicted salary is between 48000 - 72000 £ per year.
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
Pharmacovigilance Clinical Project Lead employer: Qualitas
Contact Detail:
Qualitas Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance Clinical Project Lead
✨Tip Number 1
Network with professionals in the pharmacovigilance field. Attend industry conferences, webinars, or local meetups to connect with others who work in CROs or pharmaceutical companies. This can help you gain insights into the role and potentially get referrals.
✨Tip Number 2
Familiarise yourself with the latest regulations and guidelines related to pharmacovigilance, such as ICH-GCP and GVP. Being well-versed in these will not only boost your confidence but also demonstrate your commitment to compliance during interviews.
✨Tip Number 3
Showcase your project management skills by discussing specific examples of how you've successfully led clinical projects in the past. Highlight your experience with risk management and compliance, as these are crucial for the role.
✨Tip Number 4
Prepare for potential interview questions by reviewing common scenarios faced in pharmacovigilance. Think about how you would handle challenges like adverse event reporting or stakeholder communication, as this will help you articulate your problem-solving abilities.
We think you need these skills to ace Pharmacovigilance Clinical Project Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Pharmacovigilance and project management. Emphasise your expertise in pre-marketing phases and any specific safety activities you've managed.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical research and your understanding of the role. Mention specific projects or experiences that align with the responsibilities outlined in the job description.
Highlight Relevant Qualifications: Clearly list your educational background and any certifications related to project management or Pharmacovigilance. This will help demonstrate your qualifications for the role.
Showcase Communication Skills: In your application, provide examples of how you've effectively communicated with stakeholders in previous roles. This is crucial for the position, as strong communication skills are essential for managing global teams.
How to prepare for a job interview at Qualitas
✨Showcase Your PV Expertise
Make sure to highlight your experience in pharmacovigilance and drug safety during the interview. Be prepared to discuss specific projects you've managed, particularly in pre-marketing phases, and how you ensured compliance with regulations.
✨Demonstrate Project Leadership Skills
Since this role requires strong project oversight, share examples of how you've successfully led clinical projects. Discuss your approach to risk management and how you've handled challenges in previous roles.
✨Familiarise Yourself with Relevant Regulations
Brush up on ICH-GCP, GVP, FDA/EMA regulations, and any client-specific SOPs. Being able to speak confidently about these regulations will show that you're well-prepared and knowledgeable about the industry standards.
✨Prepare for Team and Budget Management Questions
Expect questions about resource allocation and budget tracking. Have examples ready that demonstrate your ability to manage timelines and deliver projects within scope and quality standards.