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    Drug Safety Associate

    Pfizer
    0-2 years
    Not Disclosed
    Remote Australia
    10 Jan. 24, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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

    Job Title: Drug Safety Associate
    Location: Australia - New South Wales - Sydney
    Employment Type: Full-time
    Posted: 1 Day Ago
    Job ID: 4928060

    Company Overview:

    Pfizer is committed to driving breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place, and our research and development team serves as the beating heart of our mission to bring life-changing medicines to the world.

    Role Purpose:

    As a Drug Safety Associate at Pfizer, you will play a key role in supporting our drug, biologics, and medical devices surveillance program. This involves monitoring adverse events, processing clinical trials and post-marketing safety data, and ensuring compliance with regulatory requirements to enhance health and treatment outcomes.

    Key Responsibilities:

    • Surveillance Program Monitoring: Oversee the company’s drug, biologics, and medical devices surveillance program.
    • Adverse Event Reporting: Intake, evaluate, and process adverse reports for clinical trials and post-marketing activities.
    • Decision Making: Make informed decisions under supervisor direction to resolve issues, working within set procedures.
    • Regulatory Expertise: Provide expertise on regulatory requirements and corporate policies for regulatory submissions to project teams.
    • Data Analysis: Analyze post-marketing safety data, review medical literature, and support Worldwide Strategy and Regulatory teams in safety evaluations.
    • Case Processing Workflow: Determine the appropriate workflow for case processing by reviewing case criteria.

    Minimum Requirements:

    • Education: BA/BS or equivalent experience.
    • Skills: Strong analytical skills with the ability to interpret complex data.
    • Technical Proficiency: Experience using safety databases and software.
    • Communication: Excellent written and verbal communication skills.
    • Team Collaboration: Ability to work effectively in a team environment.
    • Regulatory Knowledge: Basic understanding of regulatory requirements and corporate policies.

    Preferred Requirements:

    • Experience: Prior experience in pharmacovigilance or drug safety is a plus.
    • Medical Terminology: Familiarity with medical terminology and coding systems.
    • Regulatory Knowledge: Knowledge of global regulatory requirements for drug safety.
    • Problem Solving: Strong problem-solving skills with the ability to make decisions with limited information.
    • Technical Skills: Proficiency in programming languages and frameworks.
    • Cloud Platforms: Experience with cloud platforms and services.
    • Agile Methodologies: Familiarity with agile methodologies and project management tools.

    Work Location:

    • Hybrid work arrangement (Remote and On-Site).

    Benefits:

    At Pfizer, we care about the well-being of our colleagues and offer a wide range of benefits, including:

    • Paid parental leave.
    • Access to health and wellness apps.
    • Career growth experiences program.
    • Recognition & rewards program.
    • Paid volunteer days.
    • Life insurance benefits.
    • Pfizer Learning Academy access to top content providers.
    • Access to flu vaccines and skin checks.
    • Options to purchase additional leave.
    • Salary packaging and novated lease options.
    • Benefits may vary depending on the position and location.

    Diversity, Equity, and Inclusion:

    Pfizer is dedicated to promoting a diverse and inclusive workforce. Our commitment to Diversity, Equity & Inclusion (DE&I) ensures our colleagues feel heard and cared for. We provide opportunities for engagement through Colleagues Resource Groups (CRGs) and workstreams focused on culture, reconciliation, gender equity, disability, and the LGBT+ community.

    EEO & Employment Eligibility:

    Pfizer is an equal opportunity employer and adheres to all applicable laws and regulations regarding nondiscrimination in employment.

    Job Category: Medical

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    Warsaw |

    Remote :

    Manipal | Ireland | Nairobi | Remote - Europe | Remote - South America (Latin Americal) | Switzerland | Melbourne | Remote, USA | Leinster | Texas | Springville | Remote - Africa | Belgium | Bountiful | Zaragoza | Remote | Bishop | Lousiana | Victoria | Hungary | Faridabad | Hammond | Xzagreb | Remote - Middle East | Green Way | Thailand | Castlebar | Blue Bell | Lenexa | Riga | French | Tulsa | McFarland | Slovakia | Medan | Minnesota |

    Bucharest :

    Bucharest |

    Makkah :

    Khulais | Riyadh | King Abdullah Economic City | Jeddah | Najran | Rabigh |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Brazil | Sao paulo |

    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 |