Sepracor
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Marlborough,
MA
Intake, processing and regulatory assessment of all adverse events reports (both serious and non-serious) submitted to Sepracor for its marketed products and/or products in clinical development.
Essential Functions Timely diligence, review, and processing of adverse event reports as requested in order to fulfill all regulatory reporting obligations.
Data entry into Oracle AERS safety database per department established working practices
Telephone intake and documentation of initial adverse event reports from consumers
Tracking and documentation of due diligence with reporters in the form of emails, phone calls, and/or letters in order to collect adequate clinical information
Determination of regulatory reporting requirements based on individual case assessments of seriousness, causality, and expectedness/listedness
Maintenance of accurate and thorough documentation
Minimum education requirements Bachelors
Experience required Up to 3 Years
Knowledge & skills (general and technical) Drug Safety Associate: Zero to three years of drug safety experience or equivalent in a pharmaceutical company. Sr. Drug Safety Associate: 3+ years of drug safety experience or equivalent in a pharmaceutical company.
Experience in a scientifically related field also considered. Understanding of medical terminology and principles of clinical assessment of adverse events in the context of the pharmaceutical industry desired.
Other requirements (licenses, certifications, specialized training, physical or mental abilities required) Understanding of safety/pharmacovigilance concepts and domestic/international investigational and post-marketing drug/biologic regulatory requirements
Basic understanding of computer technology, and management of relational database systems, including query capabilities
Proficiency with word processing packages (Microsoft Word, Excel, Powerpoint, etc)
Highly effective oral and written communication skills and proficiency at building consensus when working within a team environment required.
Demonstrated ability to foster and actively contribute to a team environment
Confidential Data All information (written, verbal, electronic, etc.) that an employee encounters while working at Sepracor is considered confidential.
Compliance Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sepracor are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Marlborough, MA
Marlborough, Massachusetts
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