PV Officer

PV Officer

PrimeVigilance

Lisbon, Portugal

Job Description

The PV Officer should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) and have demonstrated experience with several years in case processing. The PV Officer will be working as part of a project team, performing, and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.

Responsibilities include

• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines. As a key member there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review;
• Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations);
• Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.);
• Mentoring and training of new and more junior employees within the department, including procedure optimization and development.

Qualifications

• Life science/bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing;
• Demonstrated case processing experience;
• Time and issue management, delegation, organization and multitasking skills with good attention to detail;
• Strong interpersonal and communication skills;
• Advanced English skills, both verbal and written, at least C1.

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