Quanticate is currently seeking a Pharmacovigilance (PV) Project Manager to join our dynamic team on a 1 year contract. In this role, you will lead and manage pharmacovigilance projects, ensuring compliance with regulatory requirements while providing strategic oversight to various client engagements. The ideal candidate possesses a strong background in pharmacovigilance, project management, and enjoys collaborating with cross-functional teams.
As a PV Project Manager at Quanticate, you will be instrumental in driving project success and maintaining high-quality standards in all aspects of pharmacovigilance, including case processing, literature review, and client communication.
Key Responsibilities- Oversee all aspects of pharmacovigilance projects from initiation through to completion, ensuring timelines and deliverables are met.
- Act as the primary point of contact for clients, managing relationships and ensuring satisfaction.
- Lead project planning, execution, monitoring, and reporting activities.
- Coordinate and support cross-functional teams, providing guidance and ensuring that project milestones are achieved.
- Ensure compliance with regulatory requirements and internal SOPs.
- Manage budget and resource allocation for assigned projects.
- Conduct risk assessments and develop mitigation strategies.
Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Requirements
Educational Background:
- Bachelor’s degree in Life Sciences or a related field.
- Desirable: Advanced degree in a biological discipline.
Experience:
- 10+ years of experience in pharmacovigilance, with a focus on project management.
- PV experience gained in a CRO or PV service provider, in a customer-facing role.
- Deep understanding of pharmacovigilance regulations and guidelines (GVP, ICH).
- Proven track record of managing multi-disciplinary teams and complex projects.
- Excellent communication skills with the ability to engage stakeholders at all levels.
- Strong organizational skills with exceptional attention to detail.
- Proficiency in project management tools and software.
Top Skills
What We Do
Quanticate is a leading global data focused clinical research organisation (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance.
As experts in clinical data, Quanticate provides high quality teams that offer efficient outsourcing solutions for:
• Clinical Data Management
• Biostatistics
• SAS Programming
• Data quality oversight via Centralized Statistical Monitoring
• Medical writing
• Pharmacovigilance
Quanticate can offer study level support, functional service provision (FSP), strategic full data-services solutions or technical consultancy to meet the needs of pharmaceutical, biotechnology and device companies across the globe. Quanticate has become the supplier of choice for many companies from top tier pharmaceutical giants through to niche biotechnology and device companies.
