The Senior Benefit-Risk Associate will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.
Key responsibilities:
- 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
- Educational background in Life Sciences or Biomedical fields (Pharmacy degree preferred).
- Demonstrated previous experience in signal detection is strongly preferred.
- Strong dedication to contributing to patient safety and a proactive approach to learning.
- Excellent time and issue management skills, with the ability to delegate, multitask, and maintain strict attention to detail.
- Strong interpersonal and communication capabilities.
- Advanced proficiency in English, both verbal and written (minimum B2 level)
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
- Quality: we hold ourselves to the standard patients deserve.
- Integrity and trust: we do the right thing, especially when it is hard.
- Drive and passion: we care about the outcome, because someone is waiting on it.
- Agility and responsiveness: we move quickly, because patients cannot wait.
- Belonging: everyone is welcome, and every voice counts.
- Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.