Copy of Copy of Pharmacovigilance Benefit/risk

hace 6 meses

Madrid, España PrimeVigilance A tiempo completo

**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 Benefit/Risk Officer should be a Life science / bio medical background graduate, preferably pharmacist, with an experience in signal detection and use of signal management tools. The Benefit/Risk Officer will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.

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 Benefit/Risk Officer will be responsible for**:

- Participating in signal detection activities including set-up
- Reviewing line listings required for preparation of signal detection report
- Drafting complex signal detection reports, including quality control
- Evaluating and categorizing potential signals
- Proposing a course of action whenever a potential signal is identified
- Providing support for preparation of communication with regulatory authorities
- Record keeping and maintenance of relevant tracking tools
- Working with other company departments to ensure that signal management is conducted in accordance with relevant PrimeVigilance procedures and regulatory requirements

**Qualifications**
- Life science / bio medical background - preferably pharmacy
- Previous experience in signal detection and use of signal management tools required
- People who are excited to learn and contribute to patient safety
- 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 B2

**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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