Drug Safety Associate

0-2 years

Not Disclosed

Remote Australia Sydney

10 Jan. 23, 2025

Job Description

Job Type: Full Time Hybrid 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: Sydney, New South Wales, Australia
Employment Type: Full-Time
Posted: 1 Day Ago
Job Reference Number: 4928060

Company Overview:

Pfizer is relentlessly pursuing breakthroughs that change patients' lives. We are dedicated to bringing life-changing medicines to the world and innovating every day to make the world a healthier place. At Pfizer, we emphasize a strong set of values and offer comprehensive benefits to support the wellbeing of our employees.

Role Overview:

As a Drug Safety Associate, you will be an integral part of Pfizer’s Worldwide Medical and Safety team, supporting drug safety efforts across clinical trials and post-marketing activities. You will be responsible for monitoring the company’s drug, biologics, and medical device surveillance programs, evaluating adverse reports, and ensuring that all necessary safety data is processed and analyzed in compliance with regulatory and corporate requirements.

This role requires working within established procedures, contributing to safety data assessments, and ensuring adherence to technical and regulatory standards in the pharmacovigilance space.

Key Responsibilities:

Safety Monitoring and Reporting:

Monitor the company’s drug, biologics, and medical device surveillance programs to ensure ongoing safety.
Intake, evaluate, and process adverse event reports for both clinical trials and post-marketing activities.
Review and assess cases to determine appropriate workflow for case processing.
Ensure that case processing decisions are made within limited options and under the direction of a supervisor.
Collaborate with project teams to provide expertise on regulatory requirements for safety-related submissions.

Data Analysis and Reporting:

Support Worldwide Strategy and Regulatory teams by analyzing post-marketing safety data.
Review relevant medical literature and other related activities to identify safety signals.
Ensure that adverse reports are processed accurately and in a timely manner, in line with corporate policies and regulatory requirements.

Regulatory Compliance and Technical Expertise:

Ensure compliance with global regulatory requirements and corporate policies for regulatory submissions.
Follow established procedures and regularly review the accuracy, completeness, and technical judgment of processed cases.
Stay updated on regulatory changes and contribute to ongoing safety data evaluations.

Collaboration and Support:

Work collaboratively with cross-functional teams to ensure efficient and accurate processing of adverse event data.
Provide support to the team by offering regulatory expertise and ensuring that all case documentation complies with established guidelines.

Qualifications:

Minimum Requirements:

Bachelor’s degree (BA/BS) or equivalent qualification.
Strong analytical skills with the ability to interpret complex data.
Proficiency in using safety databases and software.
Excellent written and verbal communication skills.
Ability to work effectively in a team environment.
Basic understanding of regulatory requirements and corporate policies.

Preferred Requirements:

Experience in pharmacovigilance or drug safety.
Familiarity with medical terminology and coding systems.
Knowledge of global regulatory requirements for drug safety.
Strong problem-solving skills with the ability to make decisions in ambiguous situations.
Proficiency in multiple programming languages and frameworks.
Familiarity with cloud platforms and services.
Experience with agile methodologies and project management tools.

Work Environment:

Location: Hybrid (Work from home and on-site flexibility).
Pfizer offers competitive compensation, career growth opportunities, and a wide range of benefits including paid parental leave, health & wellness resources, and life insurance benefits.

Additional Benefits:

Paid volunteer days.
Access to top learning content via Pfizer Learning Academy.
Options for salary packaging and novated lease options.
Career development and growth experiences.
Employee wellbeing initiatives, including access to health apps and flu vaccines.

Diversity & Inclusion:

Pfizer Australia and New Zealand fosters a diverse and inclusive workforce, representing the communities we serve. We provide engagement opportunities through various Colleagues Resource Groups (CRGs), supporting cultural traditions, gender equity, disability inclusion, and LGBT+ communities.

Apply Now to join Pfizer in driving innovation and improving patient safety worldwide.

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