Regulatory and Pharmacovigilance Specialist

hace 2 semanas

Bogotá, Bogotá D.E., Colombia bioM?rieux BV A tiempo completo

Job Description

The position involves overseeing the implementation of Pharmacovigilance and Regulatory Affairs processes within our organization in Colombia.

Key Responsibilities

  • Collaborate with colleagues to ensure compliance with local laws and regulations, including adverse event reporting and drug safety oversight.
  • Execute local Pharmacovigilance and Regulatory Affairs processes and activities in alignment with our systems and Quality Management System.
  • Ensure full compliance with global and local Standard Operating Procedures and report any deviations or compliance concerns.
  • Develop and maintain local procedures for the department to ensure quality Pharmacovigilance and Regulatory Affairs data and evaluate processes for potential improvement.
  • Proactively identify procedural gaps and challenges and implement solutions in collaboration with stakeholders.
  • Set quality standards by participating in the development of SOPs and Work Instructions for affiliate activities.
  • Maintain appropriate archives to ensure work is traceable and complies with regulations.
  • Ensure prescribing information, labels, and packaging components align with regulations and core safety information.
  • Work on continuing improvements and simplification.
  • Develop and maintain a consolidation work plan and tracking system.

Regulatory Affairs:

  • Responsible for daily RA processes and activities within the countries covered by the country operation.
  • Provide strategic input and regulatory support for timely preparation and submission of new Marketing Authorization Applications to local Health Authorities.
  • Establish and maintain a strategic partnership through effective communication with Area Commercial, Medical, and Regulatory for all products.
  • Maintain product licenses in compliance with market supply and local authority expectations.
  • Coordinate and ensure timely review and approval of artworks for packaging materials for all products.
  • Support the Sales Department with Regulatory Documents for Tender Bids.

Pharmacovigilance:

  • Responsible for daily PV processes and activities within the country.
  • Day-to-day adverse events case management, including case intake and follow-up activities.
  • Ensure vendors perform case intake and follow-up activities in accordance with Global Pharmacovigilance procedures.
  • Ensure ICSR acknowledgments and reconciliation activities are managed in accordance with local procedures and pharmacovigilance legislations.
  • Responsible for local preparation and submission of aggregate reports to the Health Authority.
  • Support local pharmacovigilance audits and inspections, including readiness activities and development of corrective actions.
  • Provide support for Patient Support Programs and related activities.

Required Education, Experience, and Skills

  • +2 years in Regulatory Affairs and Pharmacovigilance at Pharmaceutical Industry.
  • Good knowledge of ICH, GMP, and local regulations.
  • Language: Advanced/Native Spanish.
  • Language: English (Reading, writing, and speaking) – Advanced level.
  • Proficient in MS Office software.
  • Attention to detail.
  • Ability to work cross-functionally in a pharmaceutical company environment.
  • Time management.
  • Good self-organization, creativity, and initiative.
  • Flexible.
  • Team-player.
  • Accurate.
  • Effective communication skills (both written and oral).
  • Ability to transmit knowledge to others.

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