Local Safety Officer
hace 1 mes
ProductLife Group is seeking a highly motivated individual to fill the role of Local Safety Officer in Mexico. As a key member of our team, you will be responsible for ensuring compliance with local and international safety regulations in the pharmaceutical industry.
Responsibilities:- Serve as the Local Safety Officer for PLG clients in LATAM, ensuring compliance with local and international regulations.
- Liaise with local regulatory authorities, staying updated on local regulations and requirements.
- Establish and maintain the Local Pharmaceutical Safety Management Framework (PSMF).
- 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.
- Collaborate with clients, affiliate departments, and third-party vendors.
- Ensure compliance with client and PLG policies and procedures to meet statutory, quality, and business requirements.
- Handle the receipt, processing, translation, and quality control (QC) tracking of safety information for PLG 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 PLG clients.
- Provide or assist in local medical information services.
- Monitor local literature and journals for products of PLG's clients in LATAM.
- Conduct QC and track results from literature monitoring activities.
- Assist in selecting and reviewing the local journal list as needed.
- Monitor Colombian/LATAM authority websites for changes in national legislation or safety information relevant to PLG clients.
- Track regulatory authority screenings and communicate results to relevant PLG clients.
- Bachelor's or Master's degree in Medicine, Pharmacy, Nursing, or a related scientific field, or equivalent experience.
- 2+ years of pharmacovigilance experience.
- 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.
- Desirable experience in screening local literature and regulatory websites.
- Desirable previous experience conducting pharmacovigilance activities in LATAM for a European company.
- 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 collaborate effectively within a team.
- Demonstrated accountability and autonomy in handling assigned tasks.
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