Local Safety Officer

PLG is currently seeking a highly motivated individual for the position of Local Safety Officer in Colombia or 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. Join us in our mission to uphold the highest standards of safety and quality in pharmaceutical products.

**Responsibilities**:
Serve as the Local Safety Officer for PLG clients in LATAM
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

**Safety Information and Medical Information Management**:
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 Colombian 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

**Local Literature and Regulatory Website Monitoring**:
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
Experience
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 Colombian 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 Colombia and 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