Qplus consult offers high-level quality services for pharmaceutical companies. Qplus consult built a solid and strong reputation within the pharmaceutical sector. Therefore, we are looking for a motivated, dynamic, and flexible Drug Safety Advisor to join our team.
What is the job about?
As a Drug Safety Advisor, you focus on providing high-quality, comprehensive, technical, and scientific information services to our customers regarding their product range. This involves supporting and enhancing the safe and effective use of products, enabling our customers to make informed decisions about their product range.
- You provide a first-line technical and scientific information service to the internal pharmacovigilance (PV) team and customers.
- You handle all medical inquiries, particularly Adverse Event Reports and pregnancy reports, in line with procedures.
- You take care of a medical evaluation of spontaneous adverse reactions.
- You contribute to and perform medical assessments of specific documents (e.g., safety profiles 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 timeframes and ensure appropriate levels of follow-up with reporters to fulfill 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 the formulation, implementation, maintenance, and tracking of local RMPs and PSURs.
- You provide a comprehensive information service to external healthcare professionals and patients on the safety of company products within the scope of Risk Minimization Measures.
- You undertake appropriate activities to train colleagues on obligations regarding AE reporting.
- You contribute to PV audits and inspections as required.
- As a part of the PV team, you ensure any drug safety activities are in line with and comply with EU-PV-legislation and procedures.
What do we expect from you?
- You have a Master’s degree in Science (e.g., Medical Doctor, Pharmacy, Chemistry, Biology, Bio-technics, Bioscience, etc.).
- You have 1-3 years of experience in the pharmaceutical sector.
- You work 5 days per week from our offices in Melsbroek (on-site).
- You have a good knowledge of pharmacovigilance processes and European PV-legislation.
- You have a C1 or C2 level in English; knowledge of another EU language is a plus.
- You can work in a fast-paced working environment.
- You are stress-resistant and work autonomously.
- You are quality-oriented and meticulous in figuring out and formatting your work.
- You are result-oriented.
What do we offer?
- Working at Qplus Consult brings new challenges and opportunities every day.
- You will be part of a dynamic, fast-growing company with a global customer base.
- Our workplace fosters a healthy environment with fresh fruit, sit-stand desks, or desk bikes/treadmills.
- Attractive and competitive basic salary.
- Additional benefits like health insurance, meal vouchers, eco vouchers, and a mobility package.
- Extensive training and great career growth opportunities.
Who are we?
With our 6 service lines (Medical Affairs, Pharmacovigilance, Quality Management, Regulatory Affairs, Auditing, and Training), we are experts in our field within the pharmaceutical industry. We emphasize our values: client first, dedication, loyalty, passion, professionalism, and performance.
Our main focus is to build long-term relationships with each of our clients to provide excellent service 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.
Ready to make an impact in the pharmaceutical sector?
Apply now by sending your resume and motivation letter!
