Pharmacovigilance Officer (senior level position)

Ergomed; Madrid; A distancia; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A global healthcare firm in Madrid is seeking a motivated PV Officer to manage pharmacovigilance activities, including case processing and report preparation. Candidates must have a life science or related degree, along with experience in pharmacovigilance. The role promotes a diverse and inclusive workplace with opportunities for career development and remote work options.

Servicios

Training and career development opportunities

Friendly, supportive working environment

Opportunity to work globally

Formación

• Demonstrated experience in Pharmacovigilance case processing.
• Strong understanding of regulations and client requirements.
• Mentoring new team members and optimizing procedures.

Responsabilidades

• Process Individual Case Safety Reports in compliance with regulations.
• Manage independent SAE / SUSAR submissions.
• Prepare database outputs for periodic reporting.
• Mentor and train junior employees.

Conocimientos

Time and issue management

Delegation

Organization

Multitasking

Attention to detail

Interpersonal skills

Communication skills

Advanced English (C1)

Educación

Life science / biomedical degree

Descripción del empleo

At PrimeVigilance PV Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability.

If you join PrimeVigilance you can expect to work with teams of different sizes from small clinical trial to large generic post‑marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them.

The PV Officer should be a Life science / biomedical background graduate or have another 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

• 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 / biomedical 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

Why PrimeVigilance

We prioritize diversity, equity and inclusion by creating an equal‑opportunity workplace and a human‑centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human‑first approach. Why? Because our people are our greatest strength, leading to our continued success in improving the lives of those around us.

We offer

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world with English as the company language
• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to welcoming your application.

Remote Work: Yes

Employment Type: Full‑time

Key Skills: Cluster, IT, B2C, Key Account, AutoCAD Drafting

Experience: years

Vacancy: 1