Senior Psmf Associate

2 semanas atrás

Lisboa, Portugal PrimeVigilance Tempo inteiro

**Company Description**
We are PrimeVigilance (part of Ergomed Group), 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.

The position is primarily responsible for the creation, maintenance and review of client Pharmacovigilance System Master Files, in line with global regulations, legislation, PrimeVigilance and Client requirements.

The position will maintain and manage PSMF for clients, activities will include PSMF:

- Authoring
- Revision
- Quality check review
- Tracking
- Attend regular PSMF meetings with internal employees and Clients.
- May provide support to audits when scope is applicable to the PSMF activities performed.
- Fulfilment of tasks assigned by the Line Manager.
- More senior colleague may perform tasks assigned as per SOP to more junior position

**Qualifications**
- Degree qualification preferred, ideally in life sciences - pharmacy, nursing or other healthcare related qualification
- Some experience/knowledge of Pharmacovigilance is required.
- Organisational skills, including attention to detail and multi tasking.
- Management skills, including time and issue management
- Excellent communication skills
- Advanced English (spoken and written)

**Additional Information** Why PrimeVigilance**

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. 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

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