Manager Drug Safety
Position Overview:
The Manager of Drug Safety is responsible for the day to day management of drug
safety surveillance processes to ensure company compliance with regulatory
requirements. The position requires strong familiarity with FDA and ICH
regulations, and hands on experience with both the clinical and post-marketing
aspects of drug safety, as well as report writing skills.
Major Position Activities & Responsibilities:
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Receive, document and assess incoming Safety information received via
telephone, fax, e-mail and US mail.
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Manage the triage, processing, review and reporting of individual case safety
reports including NDA 15-Day Alerts and IND Safety Reports including follow-up.
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Compile safety data for NDA Periodic Safety Reports and IND Annual Reports, as
well as any ad hoc reports as necessary (eg. Clinical AE listings, signaling
reports).
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Perform periodic auditing of the Drug Safety Surveillance Department.
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Develop and present training programs with regard to Drug Safety Surveillance
for Sales force, clinical department and CRO training.
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Oversee Drug Safety Records management including archiving of Drug Safety files
(electronic/DMS and hardcopy).
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Assist with development of Corporate Policy and Process Guides.
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Assist in maintenance of Safety Data Exchange/Transfer Agreements with
marketing partners.
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Participate in review of protocols, IBs, annual reports and other safety
related documents.
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Assist with writing safety segments of Investigator Meetings and present the
segment as needed.
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Participate in investigator teleconferences and clinical project team meetings
to provide information on safety reporting, regulations, etc.
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Establish and maintain good working relationships with associated groups,
especially clinical affairs, project management, regulatory affairs, legal,
marketing, medical affairs, marketing partners and CRO’s.
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Other duties as assigned.
Scope:
This position is a key position in terms of performance and growth for the Drug
Safety Department. Drug Safety Manager plays a major role in keeping the
Department in compliance with FDA and ICH regulations.
Background Qualifications:
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Must possess a Pharm.D., R.N., B.S.N., or RPh. Degree.
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Must have at least 5 years experience in Drug Safety Surveillance, and
preferably an additional 5 to 7 years in the pharmaceutical industry;
management experience/advanced management degree a plus.
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Must be experienced with MedDRA coding and drug safety application software
(Oracle AERS knowledge preferred).
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Must be able to work independently, but also function as a member of a team.
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Must be exceptionally detail-oriented and possess excellent written and verbal
communication skills (including presentation skills).
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Experience with Risk Management Plans a plus.
Interested candidates can send their resume to
jobs@sigmatau.com
