Description
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. 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 License Partners, Clinical Development, Country Organizations, and other stakeholders regarding safety data collection and data reconciliation.
- Develop and maintain expertise and knowledge of: applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices; data entry conventions; all assigned products within a therapeutic area; and search functions in the safety database.
- Consistently apply regulatory requirements and company policies.
Technical Skill Requirements
- Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is not a requirement but would be advantageous.
- 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 communication and solid writing skills.
- Fluency in spoken and written English; knowledge of additional languages would be an advantage.
- Experience and skill with medical writing an advantage.
- Critical thinking skills, process and compliance focused
Qualifications
- 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; Prefer Medical knowledge (healthcare professional), clinical experience outside of educational rotations (ie clinical experience after completing BSN, Rph, or PharmD degree).
- 4-7 years experience in Clinical Research desired.