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    Drug Safety Associate Ii, Pharmacovigilance - Us - Remote

    Worldwide Clinical Trials
    0-2 years
    Not Disclosed
    Remote, USA
    10 Jan. 17, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Who We Are

    At Worldwide Clinical Trials, we’re a global, midsize CRO committed to innovation and boundary-pushing creativity. We believe the path to curing the world’s most persistent diseases isn’t paved by those who play it safe; it’s built by those who take pioneering approaches and implement them with quality and excellence.

    With over 3,500 bright thinkers, dreamers, and doers worldwide, we’re changing the way the world experiences CROs in the best possible way. Our mission is to improve lives with passion and purpose every day, and we’re looking for others who share this commitment.

    Why Worldwide

    We believe every individual plays a vital role in making a difference for patients and caregivers. From our hands-on leaders to our supportive teams, we are dedicated to enabling professionals from all backgrounds to succeed. Our diverse, inclusive environment fosters collaboration and creativity, where everyone can thrive by being their authentic selves and doing their best work every day. Join us!

    Summary

    We are seeking a Drug Safety Specialist to join our team. In this role, you will be responsible for the collection, processing, and evaluation of Serious Adverse Events (SAEs) reported to the company. This includes preparing summary narratives, determining the proper regulatory reporting status, and entering data into the Drug Safety Database. Additionally, you will assist the Drug Safety Manager/Officer in preparing safety reports for regulatory authorities and provide routine database searching, extraction, and reporting services.

    Responsibilities
    Tasks may include, but are not limited to:

    • Evaluate case information, determine the regulatory reporting status, and accurately enter data into the safety database.
    • Provide retrieval and reporting of data from the global safety database.
    • Support the Safety Officer in generating Safety Update Reports (ASRs), Periodic Line Listings, and other regulatory reports.
    • Interact with other functions (ClinOps, Data Management) for database reconciliation.
    • Ensure all safety data is handled according to global standard operating procedures and local working practices.
    • Contribute to the preparation of study-specific Safety Monitoring Plans to handle SAE cases.
    • Support safety signal generation and evaluation processes through safety database searching.
    • Stay updated on the latest drug safety laws, guidelines, and regulations.
    • Perform additional duties as assigned.

    Other Skills and Abilities

    • Strong understanding of medical/scientific terminology, clinical assessment of adverse drug events, and international regulations.
    • Good knowledge of computer technology and relational database systems.
    • Strong written and verbal communication skills.
    • High time management and organizational skills.
    • Fluency in written and spoken English.

    Requirements

    • Bachelor’s degree in a science-related field, nursing, or equivalent.
    • Promotion to the next level is based on proven competency, level of responsibility, and the ability to work independently, not solely years of experience.

    Why Join Us
    At Worldwide, we’re proud to make a difference in people’s lives. We are an equal opportunity employer and are committed to creating a diverse and inclusive workplace where all employees have access to equal opportunities. We prioritize attracting diverse talent and fostering collaboration and creativity. When our employees feel valued and included, they can achieve greater success and innovation.

    Discover a world of difference at Worldwide! Visit our careers page or connect with us on LinkedIn for more information.

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    South Africa :

    Midrand | South Africa |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |