高级安全专员

Job Title: FSP Senior Safety Specialist
Job Location: Remote, North Carolina, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Job Description:

• Regularly monitors and manages GPS mailboxes

• Communicates with safety vendor regarding individual case safety reports (ICSR) and aggregate reports / line listings

• Manages the reviews of ICSRs, listings, tables, and figures for completeness and quality as needed

• Manages (serious) adverse event reconciliation of databases and listings (post marketing and clinical trial sources) as required

• Collaborates with internal teams (including clinical, medical, or regulatory) and external parties (including HCPs, consumers, or contracted resources) to obtain safety information

• Participates in and takes minutes of meetings as required;

• Supports the generation of aggregate safety reports

• Communicates with business partners or distributors regarding the receipt and transmission of safety information as per applicable safety data exchange agreements.

• Attends GPS operational meetings and contributes as SME to topics discussed

• Proactively identifies issues and areas for improvement and escalates appropriately

• Contributes to the development of new processes and procedures

• Supports implementation of new processes and systems as required

• Performs all activities in compliance with applicable client Controlled Procedures and with global and local regulations as applicable.

• Performs other tasks as assigned by line manager or Head of GPS

Knowledge, Skills, and Abilities:

• Fluent communication in written and spoken English

• Advanced knowledge of medical terminology, pharmacovigilance processes and relevant regulations, including global requirements (e.g. EU, US, Japan)

• Ability to communicate complex issues in an understandable, effective and relevant manner

• Ability to manage and prioritize a variety of tasks to meet required deadlines

• Ability to solve routine problems with limited supervision and to raise issues constructively

• Ability to deliver high quality documents, including work instructions, guidelines, forms and templates

• Takes ownership of assigned work and manages timelines for deliverables with minimal support

• Ability to make basic operational decisions with an understanding of the impact and potential risk

• Advanced computer skills, including proficiency with Microsoft Office

• Proficiency with safety database systems (i.e. Argus) and MedDRA coding

Education and Experience:

• Bachelor’s /Master’s degree (or local equivalent) in nursing, healthcare or other life-science or relevant field

• 3- 5 years of relevant experience in global pharmacovigilance/drug safety (EU&US)

• Equivalent and adequate combination of education and experience

• Solid experience with the end to end process of safety event collection and reporting

• Relevant experience with the development and submission of aggregate safety reports (e.g. DSUR, PSUR)

• Solid expertise of global (EU/US) pharmacovigilance requirements and practices

• Solid experience with safety database systems (e.g. ARGUS or ArisG) including workflow management

• Experience in interaction with 3rd party vendors would be a plus

• Experience with the generation and evaluation of quality metrics would be a plus

Thermo Fisher values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary for typical working hours.

• Ability to use and learn standard office equipment and technology with proficiency.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

• May require travel. (Recruiter will provide more details.)

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Originally posted on Himalayas