Safety Surveillance Associate

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

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.

How You Will Achieve It

Contribute to completion of project milestones and organize own work to meet project task deadlines.

Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission.

Support Worldwide Strategy and Regulatory teams by providing analyses of post-marketing safety data, reviews of the medical literature, and similar related activities.

Review case criteria to determine the appropriate workflow for case processing.

Position purpose

Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer's products and to meet regulatory requirements.

Responsibilities

Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.

Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately.

Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/ listedness / labeledness ); special scenarios; product complaint information; reportability with due date; and accuracy and consistency.

Based on assessment of cases, process accordingly.

Review case criteria to determine the appropriate workflow for case processing.

Write and edit the case narrative.

Generate reports, ensuring adherence to regulatory compliance timelines.

Determine and perform appropriate case follow-up, generating and requesting follow-up letters.

Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.

Develop and maintain expertise and knowledge of: all assigned products within a therapeutic area; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database.

Consistently apply regulatory requirements and Pfizer policies.

Qualifications

Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent

Ability, with supervision, to solve routine problems and to surface issues constructively.

Ability to make basic decisions with an understanding of the consequences.

Technical Skill Requirements

Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.

Demonstrated computer literacy, particularly in the use and management of relational databases.

Ability to achieve personal objectives while meeting departmental standards of performance.

Ability to work under supervision in a matrix organization.

Excellent oral and written communication skills.

Fluency in spoken and written English; knowledge of additional language(s) an advantage.

Experience and skill with medical writing an advantage.

Work Location Assignment:Hybrid

#LI-PFE

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.