Director Safety/Pharmacovigilance at ProQR Therapeutics
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 140 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
The Safety/Pharmacovigilance Department has responsibility for the overall pharmacovigilance and safety risk management system for all products.
The Director Safety/Pharmacovigilance has the overall responsibility for monitoring the safety of all products, in collaboration with other functions in ProQR.
Location: Leiden, Netherlands, but part-remote working is a possibility
Reporting to: Chief Medical Officer
- Manage all aspects of safety/pharmacovigilance activities including signal detection, risk management plans, periodic reports (DSURs and PSURs), company core safety information, benefit/risk assessments and individual safety reports for all products/trials
- Assist in the maintenance of company compliance with respect to laws, regulations and guidance associated with the safety of the patients receiving all medicinal products
- Review of safety related documents
- Provide safety/pharmacovigilance support to other functional areas in the company
- Receive safety related information from all sources, including clinical trial cases, spontaneous reports and literature reports (US and global)
- Perform triage for incoming cases, considering assessments of seriousness and causality
- Perform accurate data entry into the safety database
- Prepare high quality case narratives, including identifying relevant information from source documents
- Produce accurate safety reports (i.e. CIOMS/MedWatch Forms) for submission to regulatory authorities and partners
- Compile safety information for aggregate safety reports and other safety related reports
- Support preparation of Risk Management Plan and post-marketing safety monitoring activities
- Support preparation of drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Briefing Documents, Integrated Summary of Safety, Integrated Summary of Efficacy, MedDRA coding of AEs, product package and labelling)
- Participate in Safety Management Team meetings
Required Experience/ Qualifications
- Minimum 7 years of experience in the pharmaceutical/biotechnology industry with at least 5 years in a safety related role
- Ability to independently make informed decisions and demonstrate strong problem-solving skills
- Attention to detail and the ability to organize, analyze and summarize/present required safety data
- Ability to manage own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
- Ability to collaborate across multiple functions and therapeutic areas and to grow and develop within a team-oriented structure
- Fluent in English both written and spoken
- Clinical/graduate degree or equivalent (e.g. MD, Pharm D, Ph.D., BSN) required
- Expert knowledge of the regulations governing pharmacovigilance
- Good working knowledge of validated drug safety databases and MedDRA
We offer a competitive salary and package.
Please contact Laura Faber via email@example.com if you have any questions.
Please note that a screening is part of our selection procedure.