Safety Data Management Specialist
Job Description
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 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. Determination of local submission of individual and, where appropriate, aggregate safety reports.
Primary Responsibilities
- 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.
- 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
Technical Skill Requirements
- Experience in pharmacovigilance and/or data management preferred but not required.
- Experience and skill with medical writing an advantage
- Demonstrated computer literacy.
- Experience in use and management of relational databases preferred
Qualifications
- 1+ years of pharmacovigilance experience
- Bachelor's Degree in Health or Life Sciences
- Health Care Professional or equivalent experience preferred.
- 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
PHYSICAL/MENTAL REQUIREMENTS
- Must have the “ability to communicate,” “ability to work on teams”, “office job involving use of computer”, etc.
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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.
