5 working days 08:30 To 17:15
-
Loan -Bonus -Health insurance
-Gym facilities
-In-house Medical doctor
-Occasional packages and gifts
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201 - 500 employees
Pharmaceutical
Iranian company dealing with Iranian and foreign customers
1380
Privately held
توضیحات بیشتر
key Requirements
4 years experience in similar positionExperience in Pharmaceutical industryPhD Pharmacy/Pharmacologylanguage English-AdvancedJob Description
- Maintain effective communication channels for pharmacovigilance activities, including responding to inquiries and requests from external partners within agreed timelines.
- Liaise closely with the Iran Food and Drug Administration (IFDA) and ensure compliance with applicable pharmacovigilance regulations and requirements.
- Review and manage PVAs/SDEAs with external partners and relevant stakeholders, ensuring clear definition of responsibilities, timelines, and adherence to agreed commitments.
- Collect, assess, and report Individual Case Safety Reports (ICSRs) to external partners and the relevant health authorities within defined timelines.
- Prepare and submit periodic safety reports, including PBRERs/PSURs, as well as Risk Management Plans (RMPs), in accordance with GVP principles and regulatory requirements.
- Monitor signal detection, adverse event reporting, and ongoing safety evaluations of medicinal products.
- Conduct reconciliation activities with relevant internal departments, distribution companies, and external partners to ensure accurate and timely completion of defined processes.
- Manage the 24-hour Pharmacovigilance Hotline and facilitate the collection of adverse event reports from patients, healthcare professionals, and other sources.
- Conduct weekly literature monitoring for medicinal products and report relevant safety information to external partners and, where required, to the health authority.
- Coordinate and manage Pharmacovigilance audits and inspections.
- Develop, implement, and update internal pharmacovigilance procedures in accordance with applicable regulations and standards.
- Maintain and update pharmacovigilance information systems and safety monitoring processes within the BPMS.
- Provide pharmacovigilance training to new employees and support annual pharmacovigilance training activities across the organization.
Qualifications:
- Minimum 4 years of relevant professional experience, preferably in Pharmacovigilance.
- Solid knowledge of Pharmacovigilance principles and processes.
- Knowledge of advanced clinical data analysis and safety data assessment.
- Familiarity with GVP principles, safety reporting, and risk management processes.
- Excellent attention to detail and accuracy.
- Strong decision-making skills.
Job Requirements
Age
29 - 38 Years Old
Gender
Men / Women
Military service
Military service must be done
Education
Language
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