Drug Safety Physician - MD

Our client will consider relocation for a qualified individual.


Drug Safety Physician

Summary:

The incumbent will be globally responsible for the medical oversight of drug safety activities for all the company’s drug development programs. This position will report to the Director of Medical Affairs. Responsibilities include the medical review and decision-making for all SAEs, and the monitoring of all stages of adverse event processing, tracking, review, evaluation, reconciliation and reporting in cooperation with the global Pharmacovigilance Organization and third party CROs involved in remote/outsourced activities. The position will also include responsibilities for benefit/risk assessment and the development of trend analyses. The qualified candidate must have extensive experience in drug safety review and reporting and have a strong medical background that includes patients treated in the oncology therapeutic area. The candidate must also have a good understanding of the adverse event process with a strong working knowledge of the ICH/FDA guidelines for GCP and Clinical Safety Reporting on a global basis. This position is a critical part of the Company’s Development program and the candidate will play a major role in the development organization.

Responsibilities and Duties:

•Evaluates all SAE reports on a global basis, assessing the case reportability, labeling and causality assessments.
•Provides evaluation on the clinical context of adverse event reports and a credible assessment on the medical conditions and the implications of drugs in the reported side-effects documents.
•Ensures the completeness and accuracy of safety information in the report narrative for each SAE, especially those involving early death and/or early study termination due to toxicity.
•Examines the accuracy of coding of reported terms and case identification strategies and ensure the coding convention is followed across all projects.
•Prepares safety related sections of the IND (s), annual report, IB, ICF, CCSI, PSUR and other regulatory documents.
•Identifies safety signals based on the review of solicited or unsolicited single cases and confirms they are not overlooked.
•Determines the need and specific interest for follow-up in critical cases and guides the periodic review (or by case) reporting of the safety experience on drugs.
•Participates in the internal safety review committee and assists in the external data monitoring committee with safety related inquires.
•Contributes to safety sections of study reports, clinical summary of the NDA and product labeling.
•Prepares responses to inquiries from global regulatory authorities or health care professionals on safety issues.
•Develops documents and maintains medical guidance for the assessment of side effects regarding causality and expectedness as required.
•Collaborates productively with colleagues from all disciplines within the Company as required.
•Maintains daily communication and collaboration with all functional groups involved in the management of the drug safety process including the parent company, the parent company’s Medical Consultant, the CRO medical staff, the medical monitors and external data management vendors.
•Closely works with CRO Safety Physicians on all safety related issues including relatedness and expectedness determination.
•Maintains comprehensive documentation on the clinical experience with drugs throughout the lifetime of the product.
•Coordinates the timely review of SAEs by the entire medical advisory staff involved in the program to insure adequate discussion prior to the finalization of the SAE reports and case closure.
•Participates in the preparation and review of documents for submission to regulatory authorities including protocols, various study reports and safety sections for IND/NDA and similar submissions for other worldwide regulatory authorities, IND Annual Reports, Investigator Brochure, etc. This responsibility also includes participation in the preparation of study manuals, site manuals and other study related documents required for high quality study programs.
•Insures the correctness of drug safety related statements in all documents and S-1 development program records.
•Presents Drug Safety related information at investigator meetings and other study meetings as required.
•Supervises and conducts drug safety training for CRAs and other staff members as required.
•Evaluates and reports to management new and recurrent safety concerns. Monitors trends in the safety of the S-1 development program. Maintains awareness of developments in the field of Drug Safety surveillance, Investigator Brochures, and FDA regulations by reading relevant literature and communicating with key investigators, medical staff and consultants.
•Provides assistance with a multitude of other tasks as required in support of the S-1 development program.

If you are interested in the above opportunity, please forward your resume to in MS Word format to [Click here for email] .

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REQUIREMENTS
Educational Requirements:
Medical degree (MD) with a specialty in internal medicine or emergency/intensive care with extensive experience with oncology patients. An Oncology license certification is not required.

Experience:
A minimum of at least 3-5 years experience in Drug Safety environment with substantial experience in managing adverse event and SAE processing, risk management, and assessment on a global basis within the pharmaceutical industry. The candidate should have extensive knowledge of ICH/FDA guidelines for GCP and Clinical Safety Reporting. Experience with the use of global safety databases is a plus. Highly developed skills in verbal and written communication, planning, organization, with an extensive working knowledge of the investigational clinical study setting are mandatory.

Other Skills and Abilities:
Working knowledge of drug development process
Can work in a highly organized team environment
Good decision-making and problem solving skills coupled with a can-do attitude
Must be able to successfully manage and prioritize multiple critical issues simultaneously. Ability to multi-task on management issues
Experience with drug safety management tracking tools and electronic databases
Excellent PC skills including MS Office products (Word, Excel, and PowerPoint).
Attention to detail with a highly consistent focus on quality is mandatory
Excellence in written and oral communication is a key requirement