Instagram
youtube
Facebook

Drug Safety Associate

0-2 years
Not Disclosed
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