Scientist/Senior Scientist, QPPV Office

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 **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, including new product development. - Work closely with the RMSO and works collaboratively with others within KMS. The Scientist/Senior Scientist, QPPV Office collaborates with members of client's functional areas and LPV in their region. - Carry out structured problem-solving and Credo-based decision-making skills. - Understand the clinical application of the technology/medication and assess the potential for a hazard to result in a harm. - Critically evaluate safety data from multiple sources (post-market reports, literature, etc.), and communicate to align with GRASP (Global Risk Assessment Safety Physician) safety decisions. - Work with diverse topics simultaneously - Provide assertive inputs on issues relating to patient/ consumer safety. - Communicate effectively with cross-functional stakeholders. - Handle large data sets and draw objective conclusions using appropriate analyses. - Collaborate with multiple functions and lines of business. - Handle many products/product families simultaneously. - Manage complex products. - Meet timelines for deliverables according to SOPs. **Education and Experience:** - Healthcare professional (e.g., MD, Pharm D, RN) with at least 3 years of clinical experience. MD is preferred. Two or more years of industry experience in medical safety is preferred. - Ability to analyze, interpret and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential. - Attention to detail; Diligence in record-keeping and records organization; Ability to manage high workload and critical issues; Computer-literate and proficient in MS Office applications. - Team player; Displays initiative; Strong communication and presentation skills. - Strong collaborative and interpersonal skills; Results-oriented and able to independently create and deliver; Ability to thrive in a global, cross-functional environment. **Our Benefits:** - Flexible Working Hours - Full performance and development process with end of year reviews - Team events and end of year party - Employee satisfaction survey - your feedback is important for continuous improvement - Health Insurance **The Application Process** Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. **Who will you be working for?** **About 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 28 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! **Our Company Ethos** Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. 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. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.