[Hiring] Pharmacovigilance Physician @Med Communications International

Role Description

The Pharmacovigilance Physician is a medical physician (MD, DO, or equivalent) responsible for:

• Medical review of individual case safety reports (ICSR) to determine benefit-risk analysis.
• Providing medical assessment statements.
• Reviewing and analyzing aggregate data sets for benefit-risk assessments.
• Reviewing and interpreting clinical and post-marketing data for signal detection, evaluation, and verification.
• Participating in safety meetings with clients.
• Assisting in drafting, reviewing, and refining medical-content intensive portions of periodic safety reports (PADERs, PSURs, DSURs, PBRERs, IND Annual Reports).
• Updating Investigators Brochure (IB) and Clinical Safety Summaries (ISS).
• Handling US and international product labeling documents and ad hoc safety information requests from regulatory authorities.
• Drafting, reviewing, and refining risk management plans and risk evaluation and mitigation strategies.
• Supporting the Qualified Person for Pharmacovigilance as required.

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.

Requirements

• 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.
• Prefer board certification in related area for client being supported.
• Epidemiology degree is a plus.
• One year related pharmacovigilance experience in the pharmaceutical industry or other equivalent experience, such as clinical trial investigator, health authority inspector, epidemiologist, etc.
• Prefer proficiency with Microsoft Office and content management systems.
• 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.

Company Description