Job Description:
The Scientist/Senior Scientist – QPPV Office, Local Safety Support & Regulatory Intelligence is a safety expert who provides safety oversight, in their allocated region, for the Consumer portfolio of products throughout the life cycle of the products, including new product development.
The incumbent works closely with and partners with the RMSO to proactively collaborate with regional colleagues in R&D, Regulatory, and Quality.
The incumbent works closely alongside LPV country team leads in their region. The incumbent is a key contributor to regional safety deliverables and evaluations. The incumbent will provide backup to the RMSO and can represent the RMSO at meetings and for safety deliverables.
Key Responsibilities:
- Safety evaluations and clinical insights contributing to the completion of the regional safety deliverables for the company portfolio.
- Identification, communication and management of potential and known safety risks.
- Cross-functional collaboration within and outside KMS.
- Ability to influence and work effectively with business partners and colleagues.
- 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. Collaborates with the company's functional areas and LPV in their region.
Job Competencies:
- 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.
Job Complexities:
- 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.
Experience and Qualifications:
- Licensed MD with at least 3 years of clinical experience
- Two or more years of industry experience in foundational to intermediate Pharmacovigilance.
- Ability to analyze, interpret and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential.
- Brings strong project management and organizational skills, with the ability to coordinate multiple safety-related activities, manage timelines and deliverables, represent the company in cross-functional meetings, and collaborate effectively with international teams across EMEA.
- Demonstrates the ability to critically assess PV data, identify clinically relevant patterns or trends, and translate safety findings into meaningful clinical insights.
- Possesses a good understanding of adverse events, serious adverse events, case assessment, safety signals, and benefit-risk considerations.
- 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.
