Safety Surviellance Associate

• Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pharmaceutical s products and to meet regulatory requirements. Primary Responsibilities Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays. Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately.

• Review, rank, verify, process and document: event terms; case classifications (validity, seriousness, expectedness/listedness/labeledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly. Review case criteria to determine the appropriate workflow for case processing. Write and edit the case narrative.

• Generate reports, ensuring adherence to regulatory compliance timelines. Determine and perform appropriate case follow-up, generating and requesting follow-up letters. Liaise with key partners, including Pharmaceutical Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation. Develop and maintain expertise and knowledge of: all assigned products within a therapeutic area; applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; and search functions in the safety database. Consistently apply regulatory requirements and Pharmaceutical policies.

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Technical Skill Requirements Experience in Pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement. Demonstrated computer literacy, particularly in the use and management of relational databases.

• Ability to achieve personal objectives while meeting departmental standards of performance. Ability to work under supervision in a matrix organization. Excellent oral and written communication skills. Fluency in spoken and written English; knowledge of additional language(s) an advantage.

• Experience and skill with medical writing an advantage. Qualifications (i.e., preferred education, experience, attributes) Ability, with supervision, to solve routine problems and to surface issues constructively. Ability to make basic decisions with an understanding of the consequences. Bachelor s degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification.

• Skills:Category Name Required Experience Software Skills MS Office - Advanced Level No Additional Skills:Bachelor's Degree in scientific field required Pharmacovigilance and medical writing experience preferred.

Sneha Shrivastava

Technical Recruiter (Clinical/Scientific)

Artech Information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 

Office: 973.967.3348 | Fax: 973.998.2599

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