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