Senior Safety Data Specialist

hace 4 horas

San José, Costa Rica MSD A tiempo completo

**Job Description**:
Under the direction and supervision of a GPVCM Manager, the **Safety Data Specialist (SDS)** is responsible for the processing of adverse experience (AE) information into the global safety system for investigational and marketed products. The SDS is responsible for the triage, analysis and interpretation of AE data in accordance with our company Standard Operating Procedures (SOPs) and ICH-GCP guidelines for reporting of AEs to worldwide regulatory agencies by Global Pharmacovigilance. The SDS should develop an understanding of the importance of high quality and compliant AE case management as well as supporting activities such as training, review of corporative policies and leadership behaviors.

Roles for SDS may include: Intake and Case Processing, Record Specialist, Business Partner Liaison, and Translation and Submission.

**_ Primary activities include but are not limited to:_**
- perform analysis, triage and data entry of all adverse events information per standard operating procedures into the global our company safety database.
- through daily case prioritization activities, ensure completion of reports within the established internal, business partner and regulatory agency timelines.
- ensure quality and consistency with adverse events case management activities.
- support case translation and/or submission in compliance with specific worldwide regulatory agencies.
- index adverse events documents pushed from central receiving mailboxes to the imaging system with required attributes according to sops.
- clarify discrepancies with content and issues with format as required to ensure clarity, completeness and standardization of the incoming information to be sent to our company safety database.
- effectively communicate with internal and external stakeholders on receipt, inquiry and requests related to source documents.
- exchange communication with business partners (bps) based on agreements, to ensure compliance with internal, business partner and worldwide regulatory agency reporting requirements.
- assess and process information received from business partner liaison mailbox to guarantee all communications received are being handled appropriately, within the established time frames based on agreements with bps.
- review marketing authorization holders to determine and track documents that should be entered in our company safety database and/or sent to bps within regulatory time frames according to sops and agreements.
- successfully complete training and independence assessment activities for GPVCM specialist.

**Education**:

- Bachelor's degree and above, preferably in **veterinary medicine, bacteriology and nursing.**

**Skills**:

- Excellent organizational, workload prioritization and time management skills.
- ** Excellent overall communication skills with advanced oral and written English skills.**
- Advanced computer skills.
- Independent, strong analytical and problem solving skills.
- Good sense and awareness of regulations and policies.
- Able to work under time pressure in a changing environment with flexibility.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

**Who we are **

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for **

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diver

**Search Firm Representatives Please Rea

  • Senior Safety Data Specialist

    hace 1 día

    San José, Costa Rica Msd A tiempo completo

    The **Senior Safety Data Specialist (SSDS)** is responsible for processing adverse experience (AE) reports with high quality and compliance in the global safety system for investigational and/or marketed products, under the direction and supervision of a GPVCM Manager.The SSDS performs triage, analysis and interpretation of AE data following our Company...

  • Senior Occupational Safety Specialist

    hace 6 días

    San José, San José, Costa Rica Msd A tiempo completo

    Company OverviewMsd is a leading organization in the industry, committed to delivering exceptional results.SalaryWe offer a competitive salary that reflects the value we place on our employees' contributions.Job DescriptionThe Senior Safety Data Specialist will be responsible for ensuring the accuracy and completeness of safety data. This includes reviewing...

  • Senior Safety Data Specialist

    hace 1 día

    San José, Costa Rica Msd A tiempo completo

    **Job Description**:**Responsibilities and Primary Activities (may include but are not limited to)**:- ** Performs all core responsibilities of the Senior Safety Data Specialist (SSDS) in addition to processing of the most complex AE reports.**:- ** Independently and consistently meets Key Performance Indicators (KPIs) for quality and compliance.**:- **...

  • Safety Data Specialist

    hace 4 horas

    San José, Costa Rica MSD A tiempo completo

    **The Safety Data Specialist (SDS) is responsible for processing adverse experience (AE) information in the global safety system for investigational and/or marketed products, under the direction and supervision of a GPVCM Manager. The SDS performs triage, analysis and interpretation of AE data following our Company Standard Operating Procedures (SOPs) and...

  • Lead Safety Data Specialist

    hace 1 día

    San José, Costa Rica Msd A tiempo completo

    **Job Description**:**Job Description para Lead Safety Data Specialist.**:**Responsibilities and Primary Activities (may include but are not limited to)**:- ** Performs all core responsibilities of the Senior Safety Data Specialist (SSDS) in addition to processing of the most complex AE reports.**:- ** Independently and consistently meets Key Performance...

  • Senior Safety Data Specialist

    hace 1 día

    San José, Costa Rica Msd A tiempo completo

    **Job Description**:Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs.We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.**Responsibilities and Primary...

  • Senior Safety Data Specialist

    hace 1 día

    San José, Costa Rica Msd A tiempo completo

    **Job Description**:Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs.We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.**Responsibilities and Primary...

  • Senior Environmental Health and Safety Specialist

    hace 3 días

    San Francisco, Heredia, Costa Rica Viant Medical A tiempo completo

    About the RoleWe are seeking a highly motivated and experienced Senior Environmental Health and Safety Specialist to join our team at Viant Medical. In this role, you will be responsible for providing leadership and guidance on environmental health and safety matters, ensuring compliance with regulatory requirements, and promoting a culture of safety within...

  • Safety Data Management Specialist

    hace 4 días

    San José, Costa Rica Pfizer A tiempo completo

    Why Patients Need You Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary...

  • Safety Data Managment Specialist

    hace 1 día

    San José, Costa Rica Pfizer A tiempo completo

    Why Patients Need YouPfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes.Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary...

  • Data Safety Management Specialist

    hace 2 días

    San José, San José, Costa Rica Pfizer A tiempo completo

    Pfizer's mission is to empower healthcare decisions regarding the safe and appropriate use of medicines for patients.The role of a Senior Associate in our Medical and Safety team is crucial in connecting evidenced-based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. This involves creating frameworks...

  • Senior Technical Field Specialist

    hace 5 días

    San Francisco, Heredia, Costa Rica Ntt Data A tiempo completo

    We are currently seeking a Senior Technical Field Specialist to join our team in Costa Rica.As an IT support specialist, you will be responsible for troubleshooting and creating solutions that leverage technology to meet the end customer's business needs. This service is on-site and may include:Main ResponsibilitiesAssembly of equipment (Rollout)Relocation...

  • Safety Data Management Specialist

    hace 4 horas

    San José, Costa Rica Pfizer A tiempo completo

    Why Patients Need You Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary...

  • Safety Data Management Specialist

    hace 5 días

    San José, Costa Rica Pfizer A tiempo completo

    Why Patients Need You Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary...

  • Senior Master Data Specialist

    hace 7 días

    San José, Costa Rica Lonza A tiempo completo

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Content Review Specialist

    hace 2 días

    San José, San José, Costa Rica Amazon Support Services Costa Rica Srl A tiempo completo

    About UsAmazon Support Services Costa Rica Srl is committed to providing a globally trusted customer experience by ensuring that Prime Video provides content customers love and trust. We strive to empower customers to make informed viewing choices for themselves and their children.Job OverviewWe are seeking a skilled Content Review Specialist to join our...

  • Senior Speech Data Specialist

    hace 5 días

    San Francisco, Heredia, Costa Rica Amzn Support Srvcs Costa Rica A tiempo completo

    At Amzn Support Srvcs Costa Rica, we're seeking a highly detail-oriented and adaptable Senior Speech Data Specialist to join our team.Job SummaryWe are building the future of voice recognition for Alexa, and we need your help!You will work with various types of data, including text, speech, and video, to assess and improve Alexa's performance. Your attention...

  • Senior Data Engineer Transformation Specialist

    hace 4 días

    San José, San José, Costa Rica Growth Acceleration Partners A tiempo completo

    **Company Overview**Growth Acceleration Partners is a leading organization in the field of data engineering, with a strong focus on innovation and excellence.Our mission is to drive business growth through data-driven insights and strategic decision-making.**Job Description**We are seeking an experienced Senior Data Engineer Transformation Specialist to join...

  • Senior Credit Data Specialist

    hace 4 días

    San Francisco, Heredia, Costa Rica Moody'S A tiempo completo

    We are seeking a highly skilled Senior Credit Data Specialist to join our Data & Analytics team at Moody's.About the RoleThis is an internally facing position, reporting directly to the Team Manager. As a Senior Credit Data Specialist, you will be responsible for performing analysis to support ratings, research, and analytical outreach.Key...

  • Senior Data Analyst and S&Op Specialist

    hace 4 días

    San José, San José, Costa Rica Emerson A tiempo completo

    Job Overview: As a Senior Data Analyst and S&Op Specialist at Emerson, you will play a crucial role in driving business growth through data-driven insights and strategic planning.