September 3, 2024

Pfizer

Sydney

FULL TIME

Drug Safety Associate

Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve

You will be relied on by the company to monitor its drug, biologics and medical devices surveillance program. This will include intake, evaluation and processing of the adverse reports received. You will support the clinical trial as well as the post marketing activities.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.

About this role

This position is part of the local Drug Safety team and an entry level role which reports to the Safety Team Lead.

Primary Responsibilities

Carry out case intake activities prioritisation activities
Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency.
Review case criteria to determine appropriate workflow for case processing
Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
Determine and perform appropriate case follow-up, including generation of follow-up requests
Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation
Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
Determine reportability of scheduled reports, ensuring adherence to regulatory requirements
Consistently apply regulatory requirements and Pfizer policies
Participate, as appropriate, in local, internal and external safety activities

Technical Skill Requirements

Experience in pharmacovigilance and/or data management preferred but not required
Experience and skill with medical writing an advantage
Demonstrated computer literacy
Experience in the use and management of relational databases preferred

Qualifications (i.e., preferred education, experience, attributes)

Health Care Professional or equivalent experience preferred
Ability, with supervision, to solve routine problems and to surface issues constructively
Ability to make basic decisions with an understanding of the consequences
Ability to achieve personal objectives while meeting departmental standards of performance
Ability to work under supervision in a matrix organization
Fluency in spoken and written English

Work Location Assignment: Flexible

At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:

Paid parental leave
Access to Health & 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 & skin checks
Options to purchase additional leave
Salary packaging & novated lease options

Benefits listed may vary depending on your position and location and may be subject to change.

Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.

If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.

Medical

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