ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Associate, Aggregate Reporting Physician on a permanent basis. Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! Position Overview: The Senior Associate, Aggregate Reporting Physician position is responsible for developing, reviewing, and maintaining high-quality safety and pharmacovigilance documents that support the safety surveillance and regulatory compliance of consumer health products. It requires the ability to synthesize data from multiple sources, including individual case safety reports (ICSRs), aggregate safety data, clinical studies, epidemiological research, literature reviews, post-marketing surveillance, signal detection activities, and other safety data sources. The successful candidate will transform complex safety information into clear, concise, and scientifically accurate documents that support global pharmacovigilance activities and regulatory submissions and will work closely with Drug Safety, Medical Affairs, Regulatory Affairs, Clinical Development, Quality, and R&D teams to ensure consistent, evidence-based communication of product safety information. Main Job Tasks and Responsibilities: Prepare, review, and maintain pharmacovigilance and risk management documents for consumer health products. Synthesize safety information from multiple sources, including: Individual Case Safety Reports (ICSRs), Aggregate safety data analyses, Clinical trial safety data, Post-marketing surveillance data, Epidemiology studies, Published literature, Signal detection and evaluation activities, Benefit-risk assessments, Health Authority Assessment Reports.
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Role overview
Job description
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as an Associate, Medical Writing (MD) on a permanent basis. Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! The Medical Writer acts as a team member supporting and executing the creation and updating of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance Reports (SSCP), State of the Art Reviews (SOA) and Systematic Literature Reviews (LRR) for their assigned therapeutic area within Depuy Synthes. Main Job Tasks and Responsibilities: Performs tasks according to the assigned medical writing activities including systematic literature reviews primarily
…What they are looking for
Skills & requirements
Qualification
Education and Experience: Minimum bachelor’s degree in any life sciences field and at least 1 year of experience in medical writing, or any related field as applicable, OR Advanced/Post graduate degree in Medicine or life science (i.e; Master’s in Public Health) with any professional experience; Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly qualified personnel; The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology
Department · Medical Device
Hiring company
ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 30 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
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