12 days old

Safety Surveillance Associate

Peapack, New Jersey
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**Role Summary**

Pfizer is excited to present a Safety Surveillance Associate opening within our Safety organization. In this role you will have the charge of reviewing, preparing, and completing reports of adverse drug experiences, to determine the safety profile of Pfizer's products and to meet regulatory requirements.

**Role 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 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.

**Basic Qualifications**

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

+ 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

**Preferred Qualifications**

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

+ Knowledge of ARGUS safety database preferred

+ Knowledge of additional language(s) an advantage

+ Experience and skill with medical writing an advantage

**Additional Offer Details:**

+ **Last Date to Apply for Job: September 21st**

+ Additional Location Information: Peapack, NJ

+ Eligible for Employee Referral Bonus


**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.

Posted: 2020-09-08 Expires: 2020-10-09
Sponsored by:
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Safety Surveillance Associate

Peapack, New Jersey

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