Regional Safety Compliance Officer

hace 2 meses

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

Position Overview: ProductLife Group is actively searching for a dedicated professional to fill 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 contribution will be essential in maintaining the integrity and safety of pharmaceutical products.

Key Responsibilities:

  • Act as the Local Safety Officer for ProductLife Group clients across LATAM.
  • Engage with local regulatory bodies to remain informed about current regulations and compliance requirements.
  • Develop and uphold the Local Pharmaceutical Safety Management Framework (PSMF).
  • Assist in creating and maintaining local Standard Operating Procedures (SOPs) and agreements, including Safety Data Exchange Agreements (SDEA), Pharmacovigilance Agreements (PVA), and Technical Agreements (TA).
  • Support local Pharmacovigilance (PV) and Medical Information (MI) operations.
  • Collaborate with clients, internal departments, and external vendors.
  • Ensure adherence to both client and ProductLife Group policies to meet regulatory, quality, and business standards.

Safety and Medical Information Management:

  • Manage the receipt, processing, translation, and quality control (QC) 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 clients.
  • Provide or assist in local medical information services.

Monitoring Local Literature and Regulatory Websites:

  • Track local literature and journals relevant to ProductLife Group's clients in LATAM.
  • Perform quality control and document results from literature monitoring activities.
  • Assist in the selection and evaluation of the local journal list as necessary.
  • Monitor regulatory authority websites for updates in national legislation or safety information pertinent to clients.
  • Document regulatory authority screenings and relay findings to relevant 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 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.
  • Experience in screening local literature and regulatory websites is a plus.
  • Prior experience conducting pharmacovigilance activities in LATAM for a European company is advantageous.
  • Proficiency in MS Word and MS Excel.
  • Experience with safety databases, particularly MedDRA, is desirable.
  • Experience in local medical information activities is a plus.
  • Excellent command of English and Spanish.
  • Strong organizational and interpersonal skills.
  • Ability to work collaboratively within a team environment.
  • Demonstrated accountability and independence in managing assigned responsibilities.

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