Pfizer

Safety Surveillance Associate

Employer
Pfizer
Location
Peapack, New Jersey
Salary
Competitive
Posted
October 08 2021
Ref
4826695
Position Type
Full Time
Organization Type
Pharma
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. The position's purpose is to review, prepare, and complete reports of adverse drug experiences, to determine the safety profile of Pfizer's products and to meet regulatory requirements.

How You Will Achieve It

  • 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 appropriate case follow-up, requesting follow-up letters when appropriate.
  • 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 products within the Pfizer portfolio; 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

Must-Have
  • Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent
  • Health Care Professional (HCP), (nurse, pharmacist, etc.)
  • 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
  • Ability, with supervision, to solve routine problems and to surface issues constructively
  • Ability to make basic decisions with an understanding of the consequences


Nice-to-Have
  • Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement
  • Knowledge of additional language(s) an advantage
  • Experience and skill with medical writing an advantage


Other Job Details
  • Last Date to Apply: October 14th, 2021


Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Medical

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