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Responsibilities:
- Collect, assess, and process reports of adverse drug reactions (ADRs) from healthcare professionals, patients, and regulatory authorities.
- Monitor and evaluate safety data from clinical trials, post-marketing surveillance, and literature to identify trends and potential safety signals.
- Ensure compliance with global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH) by accurately documenting and submitting safety reports within required timelines.
- Manage Individual Case Safety Reports (ICSRs) by entering data into the pharmacovigilance database, ensuring completeness, accuracy, and adherence to regulatory timelines.
- Assist in developing Risk Management Plans (RMPs) and updating them as needed based on emerging safety data.
- Conduct periodic signal detection activities, analyzing spontaneous reports, clinical trial data, and literature to identify new safety concerns or risks.
- Prepare for and support pharmacovigilance audits and regulatory inspections by maintaining high-quality safety records and ensuring compliance with all legal obligations.
- Work closely with regulatory affairs, quality assurance, and clinical teams to support the development and implementation of safety measures for marketed products and those in development.
- Educate internal teams and healthcare professionals on the importance of drug safety, reporting procedures, and regulatory requirements.
Qualifications:
- Bachelor’s degree in Pharmacy, Medicine, or Life Sciences. A Master’s degree or specialized training in Pharmacovigilance is preferred.
- Minimum of 2 years of experience in pharmacovigilance, drug safety, or a related field.
- Knowledge of regulatory requirements for pharmacovigilance and post-marketing safety in major markets (e.g., FDA, EMA, WHO).
- Experience with safety databases (e.g., Argus, ArisGlobal) and proficiency in ICSR management.
Required Skills
- Heavy Equipment
- Healthcare
- Logistics Management
- Risk Management
- Pharmaceutical Sales
Job Details
- Location Amman - Jordan
- Industry Healthcare and Pharmaceutical
- Job Type Full-Time
- Degree Bachelor
- Experience 3 - 5
- Nationality Unspecified
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