Medical Safety Assessment Physician

TSR, Inc. Pennington, NJ
Our client, a major pharmaceutical company in Pennington NJ is seeking a Medical Safety Assessment Physician to join the Global Pharmacovigilance & Epidemiology, Research & Development team on a contracting basis. The candidate will be the Medical Safety Lead for aggregate safety reports and strategic documents, eg, safety aggregate reports and risk management plans

Responsibilities:

* Medical safety lead for aggregate safety reports and strategic documents

* Supports and/or Chairs Medical Surveillance Teams (MST) in overseeing and conducting safety data analysis

* Capable of reviewing data to perform Signal Detection/Safety surveillance; can evaluate and integrate data from multiple sources, including clinical, nonclinical and real-world, to understand and manage safety signals

* Plans risk strategy, risk assessment, and risk minimization for Client products in partnership with other Client functions

* Serves as safety consultant for product development activities.

* Leader or key contributor to safety query responses.

* Medical competency and scientific analytic skills

Qualifications:

* MD or Equivalent. Has completed a Board certification and/or relevant higher medical training.

* Previous experience as medical safety assessment physician; recent experience preparing safety aggregate reports (eg, PBRER, DSUR)

* Clinical knowledge base as demonstrated by clinical practice experience, or comparable activity

* Strong written and oral scientific communication skills

* Understanding of drug development process, with knowledge of design and execution of randomized clinical trials

* Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product

* Understanding of regulatory requirements for safety assessment and action through the life cycle of a drug product.

* Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.