Specialist, Local Medical Safety
5 дней назад
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
Job Function:
Product SafetyJob Sub Function:
PharmacovigilanceJob Category:
Scientific/TechnologyAll Job Posting Locations:
Kyiv, UkraineJob Description:
Job Description
Specialist, Local Medical Safety
Essential Job Duties and Responsibilities
This role acts as local QPPV for Ukraine and also ensures that Safety activities across the SSA Cluster, specifically Nigeria, comply with local regulations, company policies, and global standards. He/She will also collaborate with the Country Safety Head in maintaining effective pharmacovigilance and risk management systems throughout the product life cycle.
Key responsibilities include, but are not limited to, the following:
Act as local Qualified Person for Pharmacovigilance for Ukraine.
Ensuring that the Nigeria LOC Safety activities, related to J&J IM products are managed in compliance with local regulations and company policies/procedures at local, regional and global levels and in accordance with any product vigilance agreements with third party business partners.
Establish adequate collaboration with Case management members to maintain local compliance oversight on case processing, follow up requests, reconciliation, submission, and local literature search in Nigeria
Maintain overall responsibility for the coordination of safety requirements as delegated by Marketing Authorization Holders (MAH) in Nigeria.
Plan and ensure timely submission of Aggregate Reports according to local regulations, in collaboration with case management members.
Ensure that day-to-day PV functions and safety activities for J&J IM products are performed satisfactorily, and that full regulatory compliance is maintained at Local Operating Company level.
Minimum Qualification
Bachelor's degree in medical sciences (medicine, dentistry) or master's degree in pharmacy is must.
Proven ability to organize workflow activities and manage multiple critical issues.
Awareness of and familiarity with industry principles of product vigilance, drug development and pharmacology.
Knowledge of Global, Regional and Local Procedural Documents as applicable.
Computer literate with knowledge of relevant IT safety systems.
Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.
Ability to establish and maintain open relationships within the organization and with authorities.
Demonstrable knowledge of all local requirements and of global aspects of product safety.
Fluency in the national language and the English language is required.
Required Skills:
Preferred Skills:
Analytical Reasoning, Clinical Operations, Collaborating, Cross-Functional Collaboration, Detail-Oriented, Execution Focus, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Root Cause Analysis (RCA), Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Technologically Savvy-
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