Drug Safety Physician - Pharma

Job Responsibilities:

Medical reviewer will perform the overall medical review, check consistency of the information and provide the causality assessment and company clinical evaluation comment, as appropriate.

- Pharmaceutical industry experience preferred.

- Working knowledge of international regulations and guidance documents as related to worldwide reporting requirements.

- Preparation of clinical trial safety assessments, and regulatory submissions including the preparation of aggregate reports.

- Knowledge of US and EU regulations and guidelines for pharmacovigilance.

- Ability to independently solve routine problems related to the scope of work being provided and surface issues constructively.

- Demonstrated computer literacy, particularly in the use and management of relational databases

- Ability to make decisions independently in both routine and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact.

- Ability to discern when additional input/escalation is required to effectively address unique and/or complex situations.

- Ability to work independently to accomplish team goals with minimal supervision.

- Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals.

- 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.