New Vacancy: Pharmacovigilance Advisor at Acorn Regulatory
We are expanding our team again. Now, we wish to recruit a Pharmacovigilance Advisor. As usual, we welcome applications from candidates seeking to work remotely (within Ireland). We have an enlightened approach to remote working and you can read more about that here.
The Acorn Regulatory team consists of highly qualified and experienced professionals. The team is one of the most experienced and highly regarded regulatory affairs teams in Europe.
The Pharmacovigilance Advisor is responsible for carrying out pharmacovigilance activities in accordance with Good Pharmacovigilance Practices.
- Screening of worldwide (local) scientific literature.
- Evaluation and processing of Adverse Reactions Reports.
- Reporting of safety data using EudraVigilance.
- Input into extended EudraVigilance Medicinal Product Dictionary.
- Prepare and participate in regular signal detection meetings.
- Prepare and ensure submission of PSURs and Risk Management Plans in a timely manner.
- Update Pharmacovigilance System Master File as required.
- Respond to medical information queries.
- Respond to queries form regulatory authorities.
- Review product information, prepare Addendum to Clinical Overview as required.
- Liaise with the Regulatory Department to ensure label updates arising from Pharmacovigilance activities are implemented in a timely fashion.
- Identify and implement practices to improve the Pharmacovigilance system including review of SOPs as required.
- Provide Pharmacovigilance support and advice to relevant departments.
- Complete any other duties as considered necessary by the Company.
- Minimum B.Sc. or a third level qualification in a science/healthcare related discipline.
- Previous pharmaceutical experience required; 2+ years’ experience desirable, preferably in the area of Pharmacovigilance.
- Experience and knowledge GVP Guidelines.
- Excellent project management skills.
- Motivated self-starter with the ability to work independently and with minimal supervision.
- Excellent attention to detail.
- Ability to plan projects in order to meet deadlines.