drug Safety specialistPAREXEL

Why Work at Parexel
There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.
How can we help you on your journey? Find your path, and learn more on , , , , and .
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
Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Operating System and the MS Office suite (Word/Excel/Power Point)
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
Job Description
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
Creating/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.
Job Family
Medical Sciences
Parexel

Philippines
Permanent
Full-time