Regional Safety Compliance Officer

hace 2 meses

Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

ProductLife Group is in search of a dedicated professional for the role of Local Safety Officer in Mexico. This position is crucial for ensuring adherence to both local and international safety standards within the pharmaceutical sector. Your expertise will contribute significantly to maintaining the highest levels of safety and quality in pharmaceutical offerings.

Key Responsibilities:

  • Act as the Local Safety Officer for ProductLife Group clients across LATAM.
  • Engage with local regulatory bodies, ensuring awareness of current regulations and compliance requirements.
  • Develop and uphold the Local Pharmaceutical Safety Management Framework (PSMF).
  • Assist in formulating and maintaining 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) functions.
  • Collaborate with clients, internal departments, and external vendors.
  • Ensure adherence to both client and ProductLife Group policies and procedures to fulfill statutory, quality, and business obligations.

Safety Information and Medical Information Management:

  • Manage the receipt, processing, translation, and quality control (QC) tracking of safety information for ProductLife Group clients in LATAM.
  • Submit Local Individual Case Safety Reports (ICSRs) to regulatory authorities in accordance with local laws.
  • Conduct regular reconciliations to ensure effective management of vigilance reports for ProductLife Group clients.
  • Provide or assist in local medical information services.

Local Literature and Regulatory Website Monitoring:

  • Monitor local literature and journals pertinent to ProductLife Group's clients in LATAM.
  • Perform QC and track outcomes from literature monitoring activities.
  • Assist in the selection and evaluation of the local journal list as necessary.
  • Keep track of Colombian/LATAM authority websites for updates in national legislation or safety information relevant to ProductLife Group clients.
  • Document regulatory authority screenings and communicate findings to relevant ProductLife Group clients.

Qualifications:

  • Bachelor's or Master's degree in Medicine, Pharmacy, Nursing, or a related scientific discipline, or equivalent experience.
  • A minimum of 2 years of experience in pharmacovigilance.
  • Strong knowledge 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 in LATAM.
  • Desirable experience in screening local literature and regulatory websites.
  • Desirable previous experience conducting pharmacovigilance activities in LATAM for a European organization.
  • Proficiency in MS Word and MS Excel.
  • Desirable experience with safety databases, particularly MedDRA.
  • Desirable experience in conducting local medical information activities.
  • Excellent fluency in English and Spanish.
  • Strong organizational and interpersonal skills.
  • Ability to work collaboratively within a team.
  • Demonstrated accountability and independence in managing assigned responsibilities.

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