Drug Safety Advisor
Il y a 3 mois
About this offer
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** 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 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 healthcare 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 about 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 a minimum of 3 years of experience as a Medical Advisor/ Drug Safety Advisor;
- You have a strong knowledge of PV processes and European PV-legislation;
- You have a minimum level of C2 in English, the knowledge of another EU language is a plus;
- You can work in a fast-moving working environment;
- You are stress-resistant, wors autonomously and flexible;
- 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 means every day brings new challenges and opportunities;
- 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-stands desks or desk bikes/treadmills;
- Attractive and competitive basic salary;
- Additional benefits like insurances, meal vouchers, eco vouchers, company car with fuel card;
- Training and career growth opportunities.
- Contract type- Permanent- Number of hours per week- Full time- Job location- Leuvensesteenweg 643/bus 7, 1930 Zaventem, Belgium
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