Description
We are looking for a Junior Consultant to join our team.
As a junior consultant at IN2Pharma, you will be trained to support more senior colleagues in ensuring the client’s products meet the required standards of quality and safety and in ensuring regulatory compliance for a defined range of products of the client’s portfolio.
Main Areas of Responsibility
You will have the opportunity to acquire experience within one or several of the following domains:
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