Drug Safety Associate

Overview

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

A career at Pfizer offers opportunity, ownership, and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Responsibilities

Reports to Country Safety Lead and will primarily be responsible for the submission of individual and, where appropriate, aggregate safety reports. Other activities can include review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements.

- 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

Qualifications

- Health Care Professional or equivalent qualification

Technical Requirements (Minimum Requirements)

- Strong analytical skills with the ability to interpret complex data
- Demonstrated computer literacy
- Solid understanding of medical terminology
- Excellent written and verbal communication skills
- Fluency in spoken and written English
- Fluency in spoken and written Chinese
- Ability to work collaboratively in a team environment
- Ability to make basic decisions with an understanding of the consequences

Preferred Requirements

- Basic understanding of regulatory requirements and corporate policies
- Experience in pharmacovigilance or drug safety
- Experience in pharmacovigilance and/or data management preferred but not required
- Experience and skill with medical writing an advantage
- Ability, with supervision, to solve routine problems and to surface issues constructively
- Ability to achieve personal objectives while meeting departmental standards of performance
- Ability to work under supervision in a matrix organization

Work Location

Work Location Assignment: Hybrid

Benefits

- Paid parental leave
- Access to Health & Wellness apps
- Recognition & rewards program
- 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.

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