Manager, System Operations

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.

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