Sepracor
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Marlborough,
MA
The Safety Regulatory Specialist will perform a variety of complex administrative and technical tasks involved with adverse event analysis and reporting. The Safety Regulatory Specialist is responsible for submitting documents and notifications associated with Alert and 15-day expedited safety reports, including but not limited to applicable regulatory authorities, clinical sites, ethics committees, drug safety monitoring boards and licensing partners world wide. This role also includes close collaboration with Sepracor Regulatory Affairs to coordinate the associated regulatory documents and correspondence. Additionally, the Safety Regulatory Specialist will participate in compilation of data surveillance reports and creation both scheduled and ad hoc reports safety listings related to clinical trial and post-marketing regulatory reporting. The position will report directly to the Head of Safety Operations.
Essential Functions • Responsible for regulatory assessment of individual case safety reports to Regulatory Authorities world-wide.
• Determines the timeframes for compliant regulatory submission of all serious adverse experience reports received by Sepracor
• Responsible for submission of all ICSRs to Sepracor licensing partners in accordance with Pharmacovigilance exchange agreements
• Responsible for generating IND Safety reports/CIOMS forms and submitting to appropriate primary regulatory authorities associated with expedited reporting
• Responsible for notifying all competent authorities of expedited safety case reports, and when required, clinical research sites and ethics committees
• Responsible for coordinating regulatory sign-off (eg 1571) for clinical expedited safety reports
• Responsible for generating global regulatory authority correspondence pertaining to safety reports
• Responsible for tracking safety and regulatory submission within the safety database
• Responsible for monitoring global regulatory submission compliance in collaboration with the head of DSPV
• Collaborate with safety physicians to complete necessary un-blinding request forms for clinical trial cases
Minimum education requirements Bachelors
Experience required 3 - 5 Years
Knowledge & skills (general and technical) Education Bachelor’s degree in science or health related field. Prefer graduate degree or some graduate work.
Experience Minimum of 3 years of relevant work experience, preferably within the pharmaceutical or related industry. This experience could include clinical trials, regulatory or safety experience. Must have an in depth understanding of domestic and international safety reporting regulations.
Other requirements (licenses, certifications, specialized training, physical or mental abilities required) Have the ability manage multiple assignments and seek appropriate guidance to prioritize when needed. The successful candidate must be able to organize and complete assigned projects within scheduled time frames.
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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