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Location: New Jersey

1. Use proven pharmacoepidemiological experience to further develop and strengthen safety surveillance in
Adverse Events (AEs) signaling/trending including,
but not limited to:

· Using approved software tools.

· Defining the expected reaction rate, and comparing the observed to expected ratios.

· Develop case series when appropriate or necessary.

· Use all available data for the above including international, clinical trial, literature, etc.

· Estimate report rates via market research (using both internal and external sources) or distribution to define the denominator.

· Monitor signals for concomitant medication AEs.

· Define a process that addresses possible over or under reporting

· Use and design Phase IV observation epidemiological studies for a continuing evaluation of an AE profile or signal if appropriate or developing product value or further defining product use Drug exposure cohort studies

2. Global Drug Safety Surveillance, Post-Marketing and Clinical Trials

· Ensure that product safety profiles, as observed in the marketplace, are acted upon appropriately an in a timely manner, including detection of trends, cluster or other unusual or previously undetected adverse events. Coordinating and managing these processes from drug safety professional in Europe, North America, and Japan.

· Expectations to accomplish the above would include the following:

· Input (receipt and documentation of the initial AE)

· Processing (follow-up, classification, computer and electronic tools, coding, document production Medwatch, etc., reporting appropriate regulatory bodies and company dissemination as defined in SOPs)

Output and monitoring of AE signals

3. Initiate activity(ies) that implement findings resulting from above monitoring and investigative process.

4. Ensure that Company due diligence around drug safety surveillance is accurately conveyed via product labeling.

5. Review and medical management of all AE reports and evaluation of adverse drug experiences.

6. Review and medical evaluation of all serious AE information obtained during clinical studies (pre-approval) and eliminate redundancies in drug safety process.

7. Participate in medically relevant strategic discussion in MA or to the Company for relevant medical input, medical need, safety issues and other aspects that require physician input as directed by the VP, MA.

8. Plan and supervise the implementation of MedDRA worldwide. Also continue the planning and organization, with outside consultation, as needed, MedDRA training worldwide.

9. Proven Management and Leadership skills in coordinating a Global Drug Safety team. Current team located in Europe and Asia/Pacific Rim.

Required: Minimum MD degree, degree/formal studies in the field of epidemiology, and seven to ten years experience in the pharmaceutical industry, including two to five years in a significant International Drug Safety position.

Desired: MD degree and at least 10 years experience in the pharmaceutical industry and five years drug safety experience with management of international sites