Job Ref. ID:
UNITED ARAB EMIRATES
UAE (RAK head office)
Full Time Employment (Un-limited Contract)
The Pharmacovigilance Officer will act as support member for Pharmacovigilance team and its various activities. He/she will be responsible for the overall day to day management of Pharmacovigilance matters in different countries where Julphar product is marketed, and support the departmental management team for various aspects as asked by the reporting superior.
Key responsibilities & Accountability:
Prepares, analyzes, and follow-ups of AE and SAE reports in compliance with Julphar’s SOPs and applicable guidelines.
Participates in regional Health regulatory Audits.
Receives document and processes AE & SAE reports and document procedures.
Responsible for all clinical safety team members per project requiring safety surveillance.
Prepares reports (i.e. Individual Case Safety Reports, PSURs, Julphar’s Sponsored Post Authorization Safety studies etc) and notifies according to ICH-GCP guidelines and competent Authorities requirement.
Responsible for Drafting Risk Management Plans for each of the Julphar’s Product to the Health Authority.
Responsible for MedDRA Dictionary coding for ICSRs.
Supports scientific literature for regulatory department for registration or product re-registration.
Supports Clinical Trial study materials of similar products.
Supports patent information for product registration.
Preparing Signal Evaluation Reports (SERs) by reviewing individual cases for signal detection
Preferably with Master’s Degree in Pharmacy.
Bachelor’s degree in Pharmacy or any other medical field.
Minimum of 3 years of combined experience in Pharmacovigilance.
Should have excellent experience in working with Microsoft office.
Experience in EVMPD projects which includes creation and submission of EVPRMs and manual recording of terms in the European Medicines Agency (EMA) database
Experience authoring complex scientific documents
Experience producing high quality clinical/regulatory/scientific and/or medical documents
Excellent writing and communication skills
Ability to handle a high volume of tasks within a given timeline
Excellent interpersonal skills.
Knowledge of secondary research, clinical trials interpretation
Providing training to new resources and later mentoring and coaching
Ability to teach and speak to highly technical scientific audiences.
MOH UAE Approved and Registered Pharmacovigilance Officer for Julphar.
Ability to analyze, interpret, and summarize data
Basic understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
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