Job offer: Pharmacovigilance Officer

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