PV Officer (senior level position) Lisboa

PV Officer (senior level position)
Lisboa
Lisboa, Lisboa, Portugal

Company Description

We are Prime
Vigilance (part of Ergomed Group), 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 all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

Prime
Vigilance provides
- class support to our small to large pharmaceutical and biotechnology partners, maintaining
- lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical devices.

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

Come and join us in this exciting journey to make a positive impact in patients’ 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 trials to large, generic
- 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 another
- 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 Prime
Vigilance.

Responsibilities include:

1. 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
   - specific requirements and timelines. As a key member, there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review.
2. Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations)
3. Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc. )
4. Mentoring and training of new and more junior employees within the department, including procedure optimization and development.

Qualifications

1. Life science / bio medical background –
   - related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing
2. Demonstrated case processing experience
3. Time and issue management, delegation, organization, and multitasking skills with good attention to detail
4. Strong interpersonal and communication skills
5. 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
- centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow.

To succeed, we must work together with a
- 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:

1. Training and career development opportunities internally
2. Strong emphasis on personal and professional growth
3. Friendly, supportive working environment
4. 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 Prime
Vigilance could be a great company to join!

1. Quality
2. Integrity & Trust
3. Drive & Passion
4. Agility & Responsiveness
5. Belonging
6. Collaborative Partnerships

We look forward to welcoming your application.