Drug Safety Associate

Job content

Qplus Consult offers high level quality services for pharmaceutical companies. Within the pharmaceutical sector Qplus Consult built a solid and strong reputation, therefore we are looking for a motivated, dynamic and flexible Drug Safety Advisor.

What is the job about?

As a Drug Safety Advisor you will focus on providing high quality, comprehensive, technical and scientific information services for our customers on the their product range, supporting and enhancing the safe and effective use of products, enabling our customers to make informed decisions about the product range.

• You provide a first line technical and scientific information service to internal PV-team and customers
• You handle all medical enquiries, in particular, adverse event reports and pregnancy reports, in line with procedures.
• You take care of a medical evaluation of spontaneous adverse events.
• You contribute to and perform medical assessments of the specific documents (e.g. safety profile of medicines, detected scientific literature, signals, cases etc.; Periodic and Development Safety reports, Risk Management Plans, DHPC etc.)
• You report cases to EMA within defined time frames and ensure appropriate levels of follow-up with reporters to fulfil all legal and regulatory requirements
• You ensure all appropriate reports are distributed to regulatory authorities, Ethics Committees and investigators within regulated timeframes
• You provide pharmacovigilance expertise to Risk Management planning cross-functional teams with input to formulation, implementation, maintenance and tracking of local RMPs
• You provide a comprehensive information service to external health care professionals and patients on the safety of company products in the scope of Risk Minimization Measures
• You undertake appropriate activities to train colleagues on obligations with regards to AE reporting
• You contribute to the PV audits and inspections as required.
• As a part of the PV-team, you ensure any drug safety activities are in line and comply with EU-PV-legislation and procedures.

What do we expect from you?

• You have a Master’s degree in science
• You have minimum 3 years of experience as Medical Advisor/ Drug Safety Advisor
• You have a fluent spoken + written level in English and Dutch, a fluent level of French is a surplus
• You have a strong knowledge of PV processes and European PV-legislation.
• You are able to work in a fast moving working environment
• Stress-resistant, working autonomously and flexible describe you
• Quality -oriented, therefore meticulous in figuring out and formatting your work
• Result-oriented

What do we offer?

• Working at Qplus consult offers a lot of opportunities where every day will be different and challenging
• You will work in a dynamic and fast-growing company with customers worldwide.
• We offer an healthy working environment: sit-stands desks, desk bikes..
• Attractive and competitive basic salary
• Advantages: insurances, meal vouchers, eco vouchers, company car + fuel card
• Possibilities of trainings and evolutions

Who are we?

With our 6 service lines (Medical Affairs, Pharmacovigilance, Quality Management, Regulatory Affairs, Auditing and Training), we became an expert in our job within the pharmaceutical industry.

We attach a great importance to our values: client first, dedication, loyalty, passion, professionalism and performance.

Our main focus is to build a long-term relationship with each of our clients to provide a service of excellence in a timely and cost-efficient manner. To meet these expectations, we have a team of professional experts who are exceptionally highly trained and ready to provide excellent service every day.

You want to know more, take a look at our video: https://cutt.ly/6hU1k9B