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Pharmaceutical Safety Project Manager
2 weeks ago
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect talented individuals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.
Job DescriptionWe are seeking an experienced Pharmaceutical Safety Project Manager to join our team at Fortrea. As a global contract research organization (CRO), we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
The successful candidate will have a strong background in pharmacovigilance, project management, and leadership capabilities. They will be responsible for managing global or regional projects, ensuring harmonized communications and processes, and making decisions regarding adverse event reporting within guidelines.
The role will involve monitoring and managing workflows, overseeing the receipt and processing of adverse event reports, and providing oversight of EudraVigilance activities. The Pharmaceutical Safety Project Manager will also contribute to the generation and review of Time and Cost Estimates for PSS business, generate monthly status and other project-specific reports, and attend client meetings and liaise with clients as necessary.
Key Responsibilities- Manage 'Client' or 'Project' specific PSS operations associated with products including the entire adverse events process.
- Manage and process expeditable adverse events to the required standard and submit them to the client and regulatory agencies within agreed timelines.
- Provide all clients with the appropriate quality of service in a safe and cost-effective manner.
- Oversee the receipt and processing of adverse event reports.
- Contribute to the generation and review of Time and Cost Estimates for PSS business.
- Generate monthly status and other project-specific reports.
- 8+ years of experience in Pharmacovigilance.
- Experience in Project Management is mandatory.
- Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
- Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
- Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
- EudraVigilance Certification preferred.
- Knowledge of Medical Device Reporting desirable.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
We offer a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
Salary Range$90,000 - $140,000 per year