Benefit/Risk Officer
Há 1 mês
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.
Job Description
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
We look forward to welcoming your application.
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