Junior Global Risk Safety Physician

Junior Global Risk Safety Physician

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

QPPV HEAD OF SAFETY SCIENCE AND POLICY

Locatie:

Asia Pacific, Philippines, National Capital, Paranaque

Werklocatie:

Hybride

Wat je gaat doen

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.

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