Drug Safety Associate

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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