IN2Pharma
Pharmaceutical
JuniorConsultant
Neural analysis suggests this role is
optimal for Entry candidates.
“Junior Consultant at IN2Pharma. Skills: Regulatory Affairs, Quality Assurance, Pharmacovigilance. Support senior colleagues. Ensure client's products meet required standards of quality”
Industry & Context.
Problem solver
What They're Looking For.
Must Have
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), initiative, problem solver, good organizational skills, Accurate & efficient: concern for quality, compliance and consistency, Good communicator, team player
What You'll Do.
Support senior colleagues
Ensure client's products meet required standards of quality
Ensure regulatory compliance for a defined range of
Medical writing: expert reports
Medical education of sales representatives: product training on
Review and approve promotional material for medicinal and
PIL and packaging materials in line
Local Literature Review for adverse events on the
Assist in the PV quality system set-up or
Training of MAH’s employees in PV awareness
Support the QP/RP in all aspects related to
Support the QP/RP in the administrative release to
Investigate customer complaints and non-conformance issues
How You'll Work.
Communication Scope
Dutch; French; English
Full Job Description
We are looking for a **Junior Consultant** to join our team. **Main Areas of Responsibility** 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. This gives you 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 ben
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