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 Scientist/Senior Scientist, QPPV Office 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 Scientist/Senior Scientist, QPPV Office, is a safety expert responsible for providing safety oversight within their allocated region for the Consumer portfolio of products throughout the product life cycle, including new product development. The role works closely with and partners with the RMSO to proactively collaborate with regional colleagues across R&D, Regulatory, and Quality. The Scientist/Senior Scientist also works closely with LPV country team leads within their region and serves as a key contributor to regional safety deliverables and evaluations. The role provides backup support to the RMSO and may represent the RMSO at meetings and in relation to safety deliverables. Main Job Tasks and Responsibilities: Safety evaluations and clinical insights contributing to the completion of the regional safety deliverables for the client's portfolio. o Identification, communication and management of potential and known safety risk o Cross-functional collaboration within and outside KMS o Ability to influence and work effectively with business partners and colleagues o A vocal and visible champion of safety insights as a key input into product development and post-market safety surveillance strategy Work with RMSO (Regional Medical Safety Officer) to partner and align with regional cross-functional business partners and generate relevant safety assessments and reviews for their allocated region, for the Consumer portfolio of products, throughout the life cycle of the products, inc
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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 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, epidemiologica
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Skills & requirements
Qualification
Education and Experience: Advanced degree required: PharmD, PhD, MD, MPH, MS, or equivalent scientific discipline; 3–6 years of experience in pharmacovigilance, drug safety, medical writing, regulatory writing, or related pharmaceutical, consumer health, or medical device industries; 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 · Aggregate Reporting, Risk Management & Surveillance
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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