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Pharmacovigilance Specialist

King of Prussia, PA 19406

Posted: 10/24/2023 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 590254 Is job remote?: No Country: United States

Job Description

Target PR Range: MARKET RATE
*Depending on experience

Position Purpose: Provide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position.
Triage managers are responsible for the maintenance of the GCSP Global Adverse Events Inbox. This includes timely intake and triage of case reports received globally and the book in process for data entry into the Global Safety database. The role is responsible for triaging case reports regarding
seriousness, determining significance of follow-up information, performing duplicate checks and the independent handling of invalid case reports.
Accurate initial assessment by triage managers is critical for maintaining compliance with Regulatory authorities.
Triage managers will also interact with Safety Offers and license partners globally to ensure timely receipt of case reports and follow-up correspondence, and to request English translations where required. 

Triage Manager
1
• Maintenance of Global Adverse Events Inbox
• Confirm case receipt within 48 hours to sender (if required per SOP)
• Request translation from Safety Officer if source documents not received in
English
2
• Perform duplicate check in the global safety database to avoid duplicate reportingto regulators
• Prompt and accurate case entry into global safety database
• Coding of adverse events using the regulatory required MedDRA terminology
• Determination of seriousness including serious criteria for each adverse event
• Determination of reporting requirements for incoming follow-up information
(significant vs non-significant change decision)
• Perform initial checks on consistency and completeness of data
• Route case within the global safety database for full data entry
• Collaborative working with Regions colleagues to ensure case compliance
3
• Independent processing of reports of patients treated in an unapproved indication with a product that did not experience any adverse events/reactions within the global safety database
• Independent processing of invalid clinical trial cases and End point reports
4
• Paper archiving of single case report source documents (if received directly from source)
• Attach source documentation and correspondence electronically to the case in the safety database
5
• Fully responsible for processing invalid case reports and off label use case reports within the global safety database
• Documentation of follow-up activities for invalid case reports
6
• Senior team members to import E2B reports into the global safety database
7
• Collaborating with triage managers at other sites to work efficiently, cooperatively and with consistency

Education
Requires a Registered Nurse, BS/BA (or equivalent vocational education), Physician Assistant, Pharmacist, medical documentarian.

Experience
At least 1 year of medical/surgical nursing or a similar setting and 1 year of experience in pharmacovigilance, or equivalent setting. Global pharmacovigilance database knowledge is preferred along with proficient knowledge of global regulatory regulations.

Competencies
• Good knowledge of drug safety processes, pronounced expertise in Single Case Management, in terms of database, triage, and case entry
• Knowledge on product portfolio and strong understanding of medical terminology
• Strong sense of responsibility and accountability and special sense for diligence even for routine processes, proactive behavior and being able to keep timelines.
• Very good knowledge of adverse event (AE) and drug coding conventions (MedDRA,WHO-DD)
• Good knowledge of ICH principles of Serious AE(SAE)/AE reporting along with basic understanding of local and global regulatory roles and regulations
• Ability to develop cooperative working relationships
• Verbal and written communication skills in English language
• Knowledge in Good Documentation Practices & Good Pharmacovigilance Practices
• Interpersonal skills.
• Oral and written communication skills, ability to identify problems in case entry and to assist in implementation of workable solutions,
• Good knowledge of standard office software packages (Word, Excel)
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