What are the responsibilities and job description for the Safety Data Management Specialist position at 140 Pfizer Inc?
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. Determination of local submission of individual and, where appropriate, aggregate safety reports
Role Summary
- Carry out case processing activities
- Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency.Process cases based on these assessments
- Review case criteria to determine appropriate workflow for case processing
- Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
- Write and edit case narrative
- Determine and perform appropriate case follow-up, including generation of follow-up requests
Role Responsibilities
- Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
- 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
Basic Qualifications
- Bachelor's degree in clinical/medical or Life Sciences
- Demonstrated computer literacy
- Ability, with supervision, to solve routine problems and to surface issues constructively
- Ability to make basic decisions with an understanding of the consequences
- Ability to achieve personal objectives while meeting departmental standards of performance
- Ability to work under supervision in a matrix organization
- Fluency in spoken and written English
Preferred Qualifications
- Advanced degree or Health Care Professional or equivalent experience preferred, (PharmD, Nursing)
- 1+ years' experience in pharmacovigilance and/or data management preferred
- Experience and skill with medical writing an advantage
- Experience in use and management of relational databases preferred
Other Job Details:
- Last Date to Apply for Job: April 2, 2020
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.
