LOCAL SAFETY OFFICER | (JSE937)

Plg is currently seeking a highly motivated individual for the position of local safety officer in colombia. 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 colombia 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 colombia 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 li...