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. 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.

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.

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

Role and Location

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.

Work Location Assignment: Hybrid

Responsibilities

- 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

Benefits

- Promoting Health and Wellness to help colleagues maintain and improve their wellbeing. Includes health and disability insurance, preventive health programs, medical screenings, vaccines, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security with company contributions to retirement plans, life insurance and financial planning education.
- Providing Benefits and Time off for the Moments that Matter including vacation, holiday, sick leave, 12 week parental leave, caregiver leave, bereavement leave, and other country-specific programs.
- And so much more depending on country and site, including childcare facilities or discounts, on-site health or fitness centers, movement and mindfulness solutions, and flexible work options.
- Captions off, selected

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

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