SeniorFull TimeEN
Pharmacovigilance Physician
Position Summary
The Pharmacovigilance Physician is a medical physician (MD , DO, or equivalent) who has the scientific, clinical and therapeutic area expertise responsibility for medical review of individual case safety reports (ICSR) to determine benefit-risk analysis and provide medical assessment statements, review and analyze aggregate data sets from internal or external sources for benefit-risk assessments, review and interpretation of clinical and post marketing data for the purpose of signal detection, evaluation, verification, and participation in safety meetings with clients. The physician will also assist in drafting, reviewing, and refining medical-content intensive portions of periodic safety reports (PADERs, PSURs, DSURs, PBRERs, IND Annual Reports), Investigators Brochure (IB) updates, Clinical Safety Summaries (ISS), US and international product labeling documents, and ad hoc safety information requests from regulatory authorities. This position is also responsible, as required, for drafting, reviewing, and refining risk management plans and risk evaluation and mitigation strategies for the client. The Pharmacovigilance Physician will assist and support the Qualified Person for Pharmacovigilance as required.
Essential Functions
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
Essential Functions Statements:
POSITION QUALIFICATIONS
Licensed medical physician in good-standing in the state(s) of licensure (MD, DO, etc.) plus one (1) year pharmacovigilance experience or other equivalent experience. Or Unlicensed medical physician (MD, DO, etc.) with no record of past or present Medical Board disciplinary action; plus ten (10) years of combined pharmacovigilance experience, clinical healthcare provider experience, or other equivalent experience.
Competency Statements
Self-Motivated - Ability to be internally inspired to perform a task to the best of one's ability using his or her own drive or initiative.
Organized - Possessing the trait of being organized or following a systematic method of performing a task.
SKILLS AND ABILITIES
Education: Licensed medical physician in good-standing in the state(s) of licensure (MD, DO, etc.). Prefer board certification in related area for client being supported. Epidemiology degree is a plus.
Experience: One year related pharmacovigilance experience in the pharmaceutical industry or other equivalent experience, such as clinical trial investigator, health authority inspector, epidemiologist, etc.
Computer Skills: Prefer proficiency with Microsoft Office and content management systems.
Other Requirements: Understanding of legal, regulatory and compliance requirements with regards to pharmacovigilance based on global regulations for EU, FDA, Japan MHLW, UK MHRA, and other entities, and ICH guidelines.
Work Environment
Remote: Romania / Poland or Portugal
The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.
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