Safety Surveillance Associate - Psychology/Mental Health

RESPONSIBILITIES

- Reviews, prepares, and completes reports of adverse drug experiences, to determine the safety profile of the Company's products and to meet regulatory requirements.
- Identifies and selects routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
- Assesses cases to distinguish those with particular complexities and/or specific issues, and escalates appropriately.
- Reviews, ranks, verifies, processes and documents: event terms; case classifications (validity, seriousness, expectedness/listedness/labelledness); special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, processes accordingly.
- Reviews case criteria to determine the appropriate workflow for case processing.
- Writes and edits the case narrative.
- Generates reports, ensuring adherence to regulatory compliance timelines.
- Determines and performs appropriate case follow-up, generating and requesting follow-up letters.
- Liaises with key partners, including the Company's Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
- Develops and maintains 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 applies regulatory requirements and Company policies. {m}

SKILLS
Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent required; healthcare professional qualification preferred. Must have demonstrated computer literacy, particularly in the use and management of relational databases. Ability to achieve personal objectives while meeting departmental standards of performance required. Ability to work under supervision in a Matrix organization a must. Excellent verbal and written communication skills needed. Must have fluency in spoken and written English; knowledge of additional language(s) an advantage. Experience and skill with medical writing an advantage. Ability, with supervision, to solve routine problems and to surface issues constructively is necessary. Ability to make basic decisions with an understanding of the consequences required. 1-3 years of Regulatory Documentation experience desired. ARGUS experience a plus/preferred. Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement.

Synectics is an Equal Opportunity Employer.