Responsible Person GDP & Responsible Person for Information & Publicity

• RP-GDP
  • ensuring that a quality management system is implemented and maintained;
  • focusing on the management of authorised activities and the accuracy and quality of records;
  • ensuring that initial and continuous training programmes are implemented and maintained;
  • coordinating and promptly performing any recall operations for medicinal products;
  • ensuring that relevant customer complaints are dealt with effectively;
  • ensuring that suppliers and customers are approved;
  • approving any subcontracted activities which may impact on GDP;
  • ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
  • keeping appropriate records of any delegated duties;
  • deciding on the final disposition of returned, rejected, recalled or falsified products;
  • approving any returns to saleable stock;
  • ensuring that any additional requirements imposed on certain products by national law are adhered to
     
• Responsible for Information & Publicity
  • Verification of the compliance of the SPC, the leaflets and their translations
  • Gives final approval on advertising projects
  • Oversees the training of medicinal representatives who visit doctors, pharmacists and other healthcare professionals.
  • Ensures compliances of regulations on « samples »
  • Establishes an appropriate internal procedure for approving advertising and various promotional activities
  •  Responsible for the information provided by his company
  •  Ensures compliance of regulations on « premiums or advantages »
• Deputy Local Safety Officer for pharmaco-, and veterinary vigilance
• To review company procedures and implement changes to the database system conform legislation in BeNe
• To keep up to date with national and international legislation, guidelines and        customer practices & provide feedback to the organization
• To prepare & support at RIP, Pharmacovigilance and GDP inspections
• To act diligently and according to corporate complaint guidelines through receiving, documenting & prompt forwarding of complaints/ADRs (Adverse Drug Reaction)

Education/Professional experience:

• Master in Pharmaceutical Sciences, Medicines or Veterinary Medicines
• Minimum 5 years of experience in relevant role

Necessary skills/Attitude:

• Service minded & confident & tactful communicator
• Accurate & analytical mind-set
• Quality mindset
• Pro-active collaborator
• Flexible & problem solver attitude
• Strategic & project management mindset
• Able to grasp new concepts quickly and translate the impact on the business
• Able to work under pressure and strict deadlines

Knowledge:

• Professional IT literacy (Excel, MS office, database management)
• Thorough understanding of medicinal product distribution, product knowledge
• Profound knowledge of medical & medicinal legislation
• Good knowledge of Quality Management Systems, procedures & processes
• Excellent written and spoken Dutch, French & English skills, German is a plus.