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Local Safety Officer

hace 2 meses

Xico, México Groupe Productlife A tiempo completo
Job Description

Groupe Productlife is seeking a highly motivated individual to fill the position of Local Safety Officer in Mexico. As a vital member of our team, you will be responsible for ensuring compliance with local and international safety regulations in the pharmaceutical industry.

Key Responsibilities:
  • Serve as the Local Safety Officer for Groupe Productlife clients in LATAM, ensuring adherence to regulatory requirements and industry standards.
  • Liaise with local regulatory authorities, staying updated on local regulations and requirements to maintain a high level of compliance.
  • Establish and maintain the Local Pharmaceutical Safety Management Framework (PSMF), ensuring seamless integration with global standards.
  • Assist in the development and upkeep of local Standard Operating Procedures (SOPs) and agreements, including the Safety Data Exchange Agreement (SDEA), Pharmacovigilance Agreement (PVA), and Technical Agreement (TA).
  • Support local Pharmacovigilance (PV) and Medical Information (MI) activities, ensuring timely and accurate reporting.
  • Collaborate with clients, affiliate departments, and third-party vendors to ensure compliance with client and Groupe Productlife policies and procedures.
  • Manage Safety Information and Medical Information, handling receipt, processing, translation, and quality control (QC) tracking for Groupe Productlife clients in LATAM.
  • Submit Local Individual Case Safety Reports (ICSRs) to regulatory authorities as per local legislation.
  • Conduct periodic reconciliations to ensure proper management of vigilance reports for Groupe Productlife clients.
  • Provide or assist in local medical information services, ensuring accurate and timely responses to client inquiries.
  • Monitor local literature and regulatory websites for changes in national legislation or safety information relevant to Groupe Productlife clients.
  • Track regulatory authority screenings and communicate results to relevant Groupe Productlife clients.
Requirements:
  • Bachelor's or Master's degree in Medicine, Pharmacy, Nursing, or a related scientific field, or equivalent experience.
  • 2+ years of pharmacovigilance experience, with a strong understanding of both local and international regulations.
  • Essential experience in local pharmacovigilance case management, including receipt, translation, submission, and follow-up.
  • Desirable experience as a local contact person in LATAM, with proficiency in MS Word and MS Excel.
  • Desirable experience with safety databases, particularly MedDRA, and conducting local medical information activities.
  • Excellent fluency in English and Spanish, with strong organizational and interpersonal skills.
  • Ability to collaborate effectively within a team, demonstrating accountability and autonomy in handling assigned tasks.