Junior Global Risk Safety Physician
- Fonction:
- Date de publication:
- Date de fin:
- ID:
- 2507038605W
Partager cet emploi:
Kenvue recrute actuellement pour un :
Ce que nous faisons
Chez Kenvue, nous réalisons le pouvoir extraordinaire des soins quotidiens. S'appuyant sur plus d'un siècle d'héritage et enraciné dans la science, nous sommes la maison de marques emblématiques - dont NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® et BAND-AID® que vous connaissez et aimez déjà. La science est notre passion ; Le soin est notre talent.
Qui nous sommes
Notre équipe mondiale est composée de ~ 22 000 personnes brillantes avec une culture d'entreprise où chaque voix compte et chaque contribution est appréciée. Nous sommes passionnés par les idées, l'innovation et l'engagement à fournir les meilleurs produits à nos clients. Avec de l'expertise et de l'empathie, être un Kenvuer signifie avoir le pouvoir d'avoir un impact sur des millions de personnes chaque jour. Nous donnons la priorité aux personnes, nous nous soucions farouchement, nous gagnons la confiance grâce à la science et nous résolvons les problèmes avec courage - et nous vous offrons de brillantes opportunités ! Joignez-vous à nous pour façonner notre avenir et le vôtre. Pour plus d'informations, cliquez sur ici.
Role relève à :
QPPV HEAD OF SAFETY SCIENCE AND POLICYLieu :
Asia Pacific, Philippines, National Capital, ParanaqueLieu de travail :
HybrideCe que tu vas faire
The Junior Global Risk Assessment Safety Physician (JGRASP) provides medical assessment of the product information pertinent to safety risk assessment and characterization of the emerging and known product safety profiles for assigned Kenvue portfolio products. The JGRASP also ensures communication of potential and known risks, when appropriate, to direct management, regional medical management, Qualified Person for Pharmacovigilance (QPPV), and personnel in all other relevant functional areas. The JGRASP is responsible for providing medical assessment of individual and aggregate safety data, support safety concerns and safety signals assessment, development of ad hoc safety reports and PSURs/PBRERs. He/She may be assigned development and/or ownership of processes, as needed, and shall ensure that performed activities fulfill the relevant regulatory requirements and all applicable Kenvue processes.
Key Responsibilities
Safety data assessment and medical insights on safety deliverables for assigned products, including but not limited to:
- Review safety data available from external and internal sources including spontaneous adverse event reports, safety data from non-spontaneous (solicited sources), results of signal detection
- Evaluation and communication of safety-related concerns (including ESI/SSI)
- Contribution to the development of signal detection strategy
- Contribution to the development of ad hoc reports
- PSUR/PBRER reviews
- Advice on risk mitigation actions
- Contribution to safety plans for new products and indications
- Incorporates new safety data into clinical practices and initiates core data sheet and label changes.
- Gathering safety data for responding to queries from Regulatory Authorities, commercial partners and internal stakeholders on safety concerns and risk management including development of appropriate documentation
- Guides analysis of database and literature searches, making conclusions about the safety signal or efficacy (or lack thereof).
- Documents results of the data review and the conclusions, actions, and advice given.
- Leads special projects related to drug and product safety.
What We Are Looking For
Key Qualifications
- A Licensed Physician
- Relative experience is preferred but not required
- Demonstrated ability to critically evaluate and analyze safety data from multiple sources (post-market reports, literature, etc.), and communicate findings to inform stakeholders
- Demonstrated ability to understand the clinical application/use of the technology/medication/product and assess the potential for a safety risk and need for risk minimization
- Demonstrated ability to carry out structured problem-solving and decision-making skills
- Demonstrated ability to communicate effectively complex topics with cross functional stakeholders
- Highly passionate in making a positive impact consumers’ lives
What’s In It For You
- Competitive Benefit Package
- Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
- Learning & Development Opportunities
- Employee Resource Groups
- Flexible Work Arrangements
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Si vous êtes une personne handicapée, veuillez consulter notre Page d'aide aux personnes handicapées pour obtenir des informations sur la façon de demander un aménagement.