Drug safety specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included drug safety specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Conducts complete clinical reviews of all domestic and foreign adverse event reports for all Acorda investigational and marketed products
Serves as a Safety Liaison contact to other departments and Acorda licensing partners
Actively obtains follow-up through event resolution
Contributes in the conduct of ongoing safety surveillance for marketed and investigational products
Participate in clinical project teams and other interdepartmental teams supporting clinical studies
Acts as a safety representative and facilitator between external reporting sources such as call centers, CROs and investigator sites
Assist in responding to queries from health authorities or outside sources
Management and submission of Individual Case Safety Report from all Spontaneous and Solicited sources
Ensure diligent follow-up attempts to collect all necessary information for case completeness and transmit follow-up reports to the relevant Processing Center in a timely manner
Safety oversight for all local activities potentially triggering collection of safety information
Keyskills: management legal language scientific communication regulatory education approach foreign information knowledge references ethical