Website Lachman Consultants
Lachman Consultants is in need of Per Diem Consultants, who are licensed physicians with expertise in performing Health Hazard Evaluations and Health Risk Assessments. Must have demonstrable, hands-on experience that includes experience and skill in the following areas:
- Medical Degree
- Knowledge of FDA regulatory requirements pertaining to Health Hazard Evaluations (HHEs)
- Experience performing evaluations of pharmaceutical drug product and medical device health hazards, to include but not be limited to:
- Determination of whether any disease or injuries could potentially occur (or already occurred) from the use of a regulated product.
- Determination of potential health hazards with scientific documentation to support the determination.
- Assessment of potential hazard to specific segments of the patient population.
- Assessment of the degree of seriousness of the health hazard to the populations at risk.
- Assessment of the likelihood of occurrence of the hazard.
- Assessment of the consequences (immediate or long-range) of occurrence of the hazard.
- Knowledge of Pharmacovigilance / Drug Safety
- Knowledge of 21 CFR Regulations regarding Class I, II, and III recalls, market withdrawals, market corrections, and drug shortages
- Experience performing and documenting Health Risk Assessments
In addition to the knowledge and expertise requirements listed above, the candidate must demonstrate strong communication / presentation skills, verbal and written, and the ability to recognize and differentiate importance of patient safety issues and prioritize accordingly. If you meet all the qualifications, please submit your full chronological resume via the Lachman website or to firstname.lastname@example.org. No phone calls please.