Junior Consultant

We are looking for a Junior Consultant to join our team.

Main Areas of Responsibility

Medical & Regulatory Affairs

• Medical writing: expert reports, clinical evaluations, literature study
• Medical education of sales representatives: product training on medicinal or healthcare products
• Review and approve promotional material for medicinal and healthcare products
• Adapt SPC, PIL and packaging materials in line with the registration file and legislation

Pharmacovigilance (PV)

• Local Literature Review for adverse events on the MAH's medicinal products
• Assist in the PV quality system set-up or maintenance: PV SOPs, gap analysis, compliance check with applicable regulations
• Training of MAH's employees in PV awareness

Quality Assurance (QA)

• Support the QP/RP in all aspects related to quality and compliance ensuring local requirements are met
• Support the QP/RP in the administrative release to the market in compliance with procedures. This includes: QA check, CoA request, Artwork request, Contact with warehouse/supply,...
• Investigate customer complaints and non-conformance issues

Technical Skill Requirements

• Master degree in life sciences
• Good knowledge of national and European regulations and legislations for medicinal products
• Good communication skills in Dutch, French and English (both verbal and written)
• Strong initiative, problem solver and good organizational skills
• Accurate & efficient: concern for quality, compliance and consistency
• Good communicator & team player

Our offer

• A permanent full-time position with a competitive package and supplementary benefits
• Challenging and alternating job as consultant within a dynamic team
• Development opportunities by working on various projects for different pharmaceutical companies

IN2Pharma is a consulting company passionate about offering solutions in Medical, Regulatory Affairs and Quality Assurance projects for pharmaceutical and healthcare industry in Benelux.

Our offices are located in Kampenhout at the business center "Hof ter Loonst" and in Gentbrugge.