Safety Data Management Specialist

SGS Consulting; New York (NY); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

SGS Consulting seeks a pharmacovigilance specialist to support safety reporting duties, including case processing, adverse event reviews, and regulatory submissions, within a collaborative team. The role requires a health care professional background and a bachelor’s in science; English fluency is essential.

Experience in data management and medical writing is advantageous, with strong computer literacy and database skills valued.

Qualifikationen

• Experience in pharmacovigilance and/or data management
• Experience and skill in medical writing is an advantage
• Demonstrated computer literacy; relational databases experience

Aufgaben

• Review, preparation, and completion of reports of adverse drug experiences
• Determine local submission of safety reports
• Carry out case processing activities and document case information
• Liaise with partners locally and with stakeholders regarding safety data collection and reconciliation

Kenntnisse

Pharmacovigilance

Data management

Medical writing

Computer literacy

Relational databases

Ausbildung

Bachelor’s degree in science

Health Care Professional or equivalent

Jobbeschreibung

Job Responsibilities

Reports to Country Safety Lead or Safety Team Lead or Safety Officer.Review, preparation, and completion of reports of adverse drug experiences to determine the safety profile of Pfizer’s products and meet regulatory requirements.Determine local submission of individual and, where appropriate, aggregate safety reports.Carry out case processing activities.Review, rank, verify, process, and document case-related information including event terms, validity, seriousness, special scenarios, timelines, accuracy, and consistency.Review case criteria to determine appropriate workflow for case processing.Assess cases to identify particular complexities or specific issues and escalation appropriately.Write and edit case narratives.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, including review for special scenarios.Liaise with key partners locally and other stakeholders regarding safety data collection and data reconciliation.Develop and maintain expertise in applicable corporate and global regulations, guidelines, Standard Operating Procedures, data entry conventions, and safety database search functions.Determine reportability of scheduled reports and ensure adherence to regulatory requirements.Consistently apply regulatory requirements and Pfizer policies.Participate, as appropriate, in local, internal, and external safety activities.

Skills

Experience in pharmacovigilance and/or data management preferred but not required.Experience and skill in medical writing is an advantage.Demonstrated computer literacy.Experience in the use and management of relational databases preferred.

Education/Experience

Health Care Professional or equivalent experience preferred.Bachelor’s degree in a science discipline.Ability, with supervision, to solve routine problems and surface issues constructively.Ability to make basic decisions with an understanding of consequences.Ability to achieve personal objectives while meeting departmental performance standards.Ability to work under supervision in a matrix organization.Fluency in spoken and written English.