Job Description
Responsibilities:
• Providing the PSMF for drugs of the company.
• Updating the PV system of the company.
• Processing of Individual Case Safety Reports in accordance with applicable regulations, PV procedures and client specific requirements and timelines.
• Performing ICSR follow up
• Product Quality Complaint handling and interaction with Quality Assurance.
• Take any actions that may need for completion and validation of the ADRs. (Including, to visit the physicians, nurses, and other staffs in the hospitals in Tehran or other cities in the country).
• Providing the PSUR/PBRER for drugs of the company (Any drugs that we have to according Iran FDO regulations).
• MedDRA and WHO coding (If it’ll be needed)
Qualifications:
• Preferably, have a certificate in the course of Implementation of the pharmacovigilance system in pharmaceutical companies from the Iranian Clinical Pharmacists Association.
• Time management, delegation, organization, multitasking skills, and good attention to detail
• Additional language skills are an advantage
