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Drug Safety Specialist
ParexelPhilippines, Philippines16 days ago
Job descriptionCreating / generating AE / Product Complaint forms in the Product Complaint System Keeping track of the Product Quality Complaints Performing clear and accurate data capture of cases (including serious and non-serious cases from spontaneous and clinical trials origin, literature and E2B cases, as applicable) and appropriate medical assessment (including company causality and assessment of expectedness) of cases in accordance with client conventions / guidelines and Standard Operating Procedures Reviewing ancillary documentation accompanying the reports and identifying the relevant information for processing and electronic capture in the applicable database Maintaining an excellent knowledge of case processing conventions and guidelines, client's procedures and international drug safety regulations Maintaining a good working knowledge of the AE safety profile of assigned products and labeling documents Ensuring MedDRA coding in accordance with "MedDRA Term Selection : Points to Consider", where applicable Interacting with internal or external contacts to resolve issues related to the processing of cases and PQCs Responding to clients / customers in a timely manner Performing triage of literature abstracts and / or full articles for validity, if required Performing single case creation / initiation in the safety database, if required Mentoring new recruits in the team, if required Identifying areas of concern within the team and raising the issues with the Team Lead Maintaining an awareness of the performance metrics measured by client and striving to remain within established limits Note : The above statements describe the general nature and level of work being performed, and are not an exhaustive list of all responsibilities required for the position. Qualifications Qualifications and Experience Science / Medicine degree : The minimum qualification required would be a University degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.) A degree in Medicine / Dentistry / Physiotherapy / Experimental Medicine, which involves patient exposure in hospital based environment, would be an advantage Good knowledge of medical terminology 1~2 years' previous PV experience Fluency in written and spoken English Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text Ability to evaluate data and draw conclusions independently Typing and transcription accuracy Team player
Basic Function : Responsible for capturing and assessing single adverse event reports associated with client products on the client's Drug Safety database, in accordance with international and local regulatory requirements
- Principal Functional Responsibilities :
- Determining the category of information received i.e.
whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and guidelines
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Specialist • Philippines, Philippines