Pharmacovigilance Officer - Russian speaker

Ergomed; Madrid; Presencial; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

A specialized pharmacovigilance service provider is looking for a PV Officer in Madrid. The role involves processing Individual Case Safety Reports and managing SAE/SUSAR submissions. Candidates should have a healthcare related degree and experience in pharmacovigilance case processing, along with strong interpersonal and communication skills. The company offers training, career development opportunities, and a supportive working environment.

Servicios

Training and career development opportunities

Friendly, supportive working environment

Opportunity to work with international colleagues

Formación

• Life science / bio‑medical background with demonstrated experience in case processing.
• Experience in Pharmacovigilance case processing required.
• Advanced English skills, at least C1.

Responsabilidades

• Processing of Individual Case Safety Reports in compliance with regulations.
• Independent SAE/SUSAR Management.
• Preparation of database outputs for periodic reporting.
• Mentoring and training of new employees.

Conocimientos

Time management

Issue management

Organizational skills

Multitasking

Attention to detail

Interpersonal skills

Communication skills

Advanced English skills

Educación

Healthcare related degree

Herramientas

ARGUS

Descripción del empleo

Company Description

We are PrimeVigilance (part of Ergomed PLC), a specialised mid‑size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well‑being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high‑quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Description

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 / bio‑medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) and have demonstrated experience 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. PV Officers are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion.

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 optimisation 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
• ARGUS experience preferred
• Time and issue management, delegation, organisation and multitasking skills with good attention to detail

• Strong interpersonal and communication skills
• Advanced English skills, both verbal and written, at least C1

Additional Information

Why PrimeVigilance?

We prioritise diversity, equity, and inclusion by creating an equal opportunities 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 on 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

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to welcoming your application.