Pharmacovigilance Officer - Russian speaker

Pharmacovigilance Officer - Russian speaker

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Vigilance.

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Company Description

We are Prime
Vigilance (part of Ergomed PLC), a specialised
- 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 covering services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

Prime
Vigilance provides first class support to our 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 Prime
Vigilance, 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 Prime
Vigilance, 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 (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 Prime
Vigilance. 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, Prime
  Vigilance procedures and in accordance with client specific requirements and timelines. Expected 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
• ARGUS experience preferred
• 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 Prime
Vigilance?

We prioritize 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. 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.

Core Values

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

We look forward to welcoming your application.

Seniority Level

Entry level

Employment Type

Full‑time

Job Function

Legal

Industry

Pharmaceutical Manufacturing