Blog

OPEN POSITION: Regulatory affairs and pharmacovigilance specialist
News Open Position

OPEN POSITION: Regulatory affairs and pharmacovigilance specialist

Sinceritas is now accepting applications for a ‘Regulatory affairs and pharmacovigilance specialist’ position. Interested? Read more for details on responsibilities and needed qualifications.

Regulatory and pharmacovigilance specialists help ensure that drugs and medical products meet certain regulations before being placed on the market. They coordinate with pharmaceutical companies and scientists to facilitate drug research, plan drug trials, and review and interpret scientific report data. They also apply for approvals and permits from the drug agency. The Regulatory and pharmacovigilance specialists might coordinate with international regulatory offices as well.

RESPONSIBILITIES:

  • Ensures compliance with applicable laws, rules and regulations
  • Establishes and submits applications for approval of drugs
  • Compiles and submits documents to regulatory agencies
  • Participates as a member of the regulatory team
  • May review promotional and advertising material for medicines to ensure compliance with regulations
  • Responds to regulatory institutions and meets deadlines
  • Manages, reviews and writes regulatory requirements
  • Reviews change controls for regulatory requirements and their compliance with relevant regulations and guidelines for maintaining the safety and efficacy of the drug
  • Responsible person for pharmacovigilance involving knowledge on pharmacovigilance requirements and procedures of periodic reporting
  • Processes cases in database, data entry, MedDra coding, narrative writing, filling-in and preparing ICSR, SAE/AE reports
  • Prepares compliance reports with contracting companies
  • Participates in document preparation within the QA (Quality Assurance) Department
  • Other responsibilities assigned by qualifications and education

QUALIFICATIONS:

  • Bachelor degree in pharmacy or medicine
  • Previous experience in a similar role
  • Detail oriented professional (one oversight could have damaging implications for safety, or could delay the release process of a life-saving drug)
  • Knowledge of scientific and research methods
  • Problem solving skills
  • Negotiation skills
  • Analytical skills
  • Excellent organizational skills
  • Computer skills
  • Ability to work independently or as part of a team
  • Excellent understanding of English – should be able to read and understand scientific documents
  • Ability to handle stress – meet short deadlines and work well in a fast-paced environment
  • Ability to manage large projects and deadlines
  • Excellent communication skills

The Regulatory and pharmacovigilance specialist’s working hours are Monday to Friday, 08:30 to 16:30 at the Sinceritas Production Facility in Rosoman, Kavadarci.

If interested in joining #TeamSinceritas, please send your updated resume to hr@sinceritas.eu with the subject line reading: Application for the Regulatory and pharmacovigilance specialist position