Local Safety Officer

hace 7 meses


Desde casa, Colombia ProductLife Group A tiempo completo

PLG is currently seeking a highly motivated individual for the position of Local Safety Officer in Colombia or Mexico. As a vital member of our team, you will be responsible for ensuring compliance with local and international safety regulations in the pharmaceutical industry. Join us in our mission to uphold the highest standards of safety and quality in pharmaceutical products.

**Responsibilities**:
Serve as the Local Safety Officer for PLG clients in LATAM
Liaise with local regulatory authorities, staying updated on local regulations and requirements
Establish and maintain the Local Pharmaceutical Safety Management Framework (PSMF)
Assist in the development and upkeep of local Standard Operating Procedures (SOPs) and agreements, including the Safety Data Exchange Agreement (SDEA), Pharmacovigilance Agreement (PVA), and Technical Agreement (TA)
Support local Pharmacovigilance (PV) and Medical Information (MI) activities
Collaborate with clients, affiliate departments, and third-party vendors
Ensure compliance with client and PLG policies and procedures to meet statutory, quality, and business requirements

**Safety Information and Medical Information Management**:
Handle the receipt, processing, translation, and quality control (QC) tracking of safety information for PLG clients in LATAM
Submit Local Individual Case Safety Reports (ICSRs) to Colombian regulatory authorities as per local legislation
Conduct periodic reconciliations to ensure proper management of vigilance reports for PLG clients
Provide or assist in local medical information services

**Local Literature and Regulatory Website Monitoring**:
Monitor local literature and journals for products of PLG’s clients in LATAM
Conduct QC and track results from literature monitoring activities
Assist in selecting and reviewing the local journal list as needed
Monitor Colombian/LATAM authority websites for changes in national legislation or safety information relevant to PLG clients
Track regulatory authority screenings and communicate results to relevant PLG clients
Experience
Bachelor’s or Master’s degree in Medicine, Pharmacy, Nursing, or a related scientific field, or equivalent experience
2+ years of pharmacovigilance experience
Strong understanding of both local Colombian and international regulations
Essential experience in local pharmacovigilance case management, including receipt, translation, submission, and follow-up
Desirable experience as a local contact person in Colombia and LATAM
Desirable experience in screening local literature and regulatory websites
Desirable previous experience conducting pharmacovigilance activities in LATAM for a European company
Proficiency in MS Word and MS Excel
Desirable experience with safety databases, particularly MedDRA
Desirable experience in conducting local medical information activities
Excellent fluency in English and Spanish
Strong organizational and interpersonal skills
Ability to collaborate effectively within a team
Demonstrated accountability and autonomy in handling assigned tasks


  • Local Safety Officer

    hace 7 meses


    Desde casa, Colombia ProductLife Group A tiempo completo

    PLG is currently seeking a highly motivated individual for the position of Local Safety Officer in Colombia. As a vital member of our team, you will be responsible for ensuring compliance with local and international safety regulations in the pharmaceutical industry. Join us in our mission to uphold the highest standards of safety and quality in...


  • Desde casa, Colombia IQVIA A tiempo completo

    **PURPOSE** Act as local contact for pharmacovigilance for customers requiring the services for their product(s). **RESPONSIBILITIES** - Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies...


  • Desde casa, Colombia Fos Feminista A tiempo completo

    **About Fòs Feminista** Fòs Feminista is an intersectional feminist organization centered around the sexual and reproductive rights and needs of women, girls, and gender-diverse people. Led and governed by the Global South, Fòs Feminista works as an alliance of organizations in 40+ countries worldwide to advance sexual and reproductive health, rights,...

  • Fol Monitor

    hace 6 meses


    Desde casa, Colombia Amentum A tiempo completo

    **THIS POSITION ONLY APPLIES FOR COLOMBIAN NATIONALS** Technical degree in Aviation Maintenance Management, Aerospace Engineering, or a related field. Minimum of 8 years related aviation line-maintenance experience in the military commercial aviation field. Minimum of 4 years' experience as a licensed aviation quality control inspector. Possess a FAA...

  • Site Care Partner

    hace 7 meses


    Desde casa, Colombia Parexel A tiempo completo

    Colombia, Remote **Job ID** R0000020545 **Category** Clinical Trials **ABOUT THIS ROLE**: Parexel FSP is hiring multiple Site Care Partners to support the Colombia region-these are great opportunities for experienced CRAs seeking career advancement! **Job Summary** The Site Care Partner is the main client point of contact for investigative sites...

  • Software Developer Iv

    hace 7 meses


    Desde casa, Colombia DreamHost, LLC A tiempo completo

    **Overview**: We are seeking a Software Developer IV to focus on implementing and optimizing WordPress solutions, delivering technical solutions aligned with the roadmap's goals, emphasizing Content Delivery Network (CDN) deployment, performance enhancement, customer experience, and tool development. In this opportunity, you will report to the VP of Software...


  • Desde casa, Colombia SCS Global Services A tiempo completo

    **Company Overview** **Job Overview** The Technical Specialist is responsible for conducting audits in accordance with RSPO Principles and Criteria, RSPO Supply Chain standards, and quality management systems. The position involves travel to conduct on-site audits in accordance with certification standards, and administrative tasks according to the program...

  • Logistics Director

    hace 7 meses


    Desde casa, Colombia Zayo Group A tiempo completo

    Company Description Zayo provides mission-critical bandwidth to the world’s most impactful companies, fueling the innovations that are transforming our society. Zayo’s 141,000-mile network in North America and Europe includes extensive metro connectivity to thousands of buildings and data centers. Zayo’s communications infrastructure solutions include...


  • Desde casa, Colombia Zayo Group A tiempo completo

    Company Description Zayo provides mission-critical bandwidth to the world’s most impactful companies, fueling the innovations that are transforming our society. Zayo’s 141,000-mile network in North America and Europe includes extensive metro connectivity to thousands of buildings and data centers. Zayo’s communications infrastructure solutions include...


  • Desde casa, Colombia Olly Olly A tiempo completo

    **_Since English proficiency is a requirement for the position, we will only be considering CV's in English. Thank you, and we look forward to your submission!_**: **About Olly Olly**: Welcome to Olly Olly, where the spirit of innovation meets the heartbeat of small businesses. Founded in 2018, Olly Olly is more than a digital marketing agency—we're a...


  • Desde casa, Colombia Mondelēz International A tiempo completo

    **Job Description**: **Are You Ready to Make It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It Matter.** This is an exciting role where you will learn to use market insights and data analysis to work with different partners to start and shape new market trends. You will support the development and execution...


  • Desde casa, Colombia SCS Global Services A tiempo completo

    **Job Overview** The position of Marketing Coordinator for the International Business team involves working directly with the Sales Team for various programs and countries; in addition to attending the organization marketing guidelines. The primary objective of the Junior Marketing Coordinator role is to implement the marketing strategy and initiatives, to...


  • Desde casa, Colombia iSPOT HOMES, LLC A tiempo completo

    iSPOT HOMES LLC, a dynamic real estate investment company, has consistently witnessed revenue growth since its establishment in 2018. Our small business thrives on rapid changes while prioritizing internal development and promoting from within. We firmly believe that our people are our greatest investment, and we are committed to building a culture rooted in...

  • Account Coordinator

    hace 7 meses


    Desde casa, Colombia Olly Olly A tiempo completo

    **About Olly Olly**: Hi, we're Olly Olly. We're a small-ish, but mighty team of digital marketing strategists, creative visionaries, graphic designers, developers, copywriters and account managers who solve problems — and we do it creatively. Our mission is to rid small businesses of sub-standard marketing help and provide "guaranteed happiness" to all our...


  • Desde casa, Colombia J.S. Held A tiempo completo

    The Company **Are you looking to join an organization that is growing and dynamic? What about a high-energy, collaborative environment that rewards hard work?** J.S. Held is a global consulting firm providing technical, scientific, and financial expertise across all assets and value at risk. Our professionals serve as trusted advisors to organizations...