Scientist/Senior Scientist, QPPV Office
ClinChoice
- Location
- Yerevan, Armenia
- Work model
- On-Site
- Level
- Senior
- Posted
- 1h ago
About this role
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;