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Clinical Trial Coordinator

1 semana atrás

Lisboa, Lisboa, Portugal PrimeVigilance Tempo inteiro
About Us

We are PrimeVigilance, a trusted partner in pharmacovigilance services. Our team consists of experienced professionals dedicated to delivering high-quality support to pharmaceutical and biotechnology companies. With a strong presence in Europe, North America, and Asia, we cover a wide range of services, including Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

Our goal is to provide exceptional service to our clients, helping them navigate the complexities of the industry. We believe in building long-term relationships, founded on trust, expertise, and a commitment to excellence.

Job Responsibilities

PV Officers play a critical role in managing case processing services, ensuring compliance with regulations, and meeting client expectations. They work closely with project teams, performing and supporting pharmacovigilance activities on behalf of PrimeVigilance.

PV Officers are responsible for:
  • Managing Individual Case Safety Reports from various sources, adhering to regulatory requirements and client specifications.
  • Leading Independent SAE/SUSAR Management, including submissions, unblinding, and clinical trial reconciliations.
  • Preparing database outputs for regular reporting, such as PBRER, DSUR, and PADER.
  • Mentoring and training new employees within the department, focusing on procedure optimization and development.

Requirements

PV Officers require a lifescience or biomedical background, preferably with a healthcare-related degree (chemistry, biology, biotechnology, veterinary science). They must also possess demonstrated experience in Pharmacovigilance case processing.

Key qualifications include:
  • Demonstrated case processing experience.
  • Excellent time and issue management skills, with ability to delegate, organize, and multitask.
  • Strong interpersonal and communication skills.
  • Advanced English skills, both verbal and written, at least C1.

What We Offer

We prioritize diversity, equity, and inclusion, creating a welcoming environment for people from diverse backgrounds to grow and contribute. Our human-first approach enables us to succeed together, leveraging our collective strengths to improve lives.

We provide internal training and career development opportunities, emphasizing personal and professional growth. Our friendly, supportive working environment fosters collaboration and innovation. You'll have the chance to work with colleagues worldwide, using English as our common language.