Safety Surveillance Associate

SAFETY SURVEILLANCE 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 Pfizers 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.

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

• Bachelors degree in a science-related field pharmacy nursing or equivalent; healthcare
• Professional qualification required.
• 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.
• Ability with supervision to solve routine problems and to surface issues constructively.
• Ability to make basic decisions with an understanding of the consequences.

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