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Director, Operations - GPRM
From:
Company: Elan Pharmaceuticals (see all of this employer's jobs)
Phone: 6508777647
Fax: 1234567890
 Apply by eMail:do_not_reply@invalidemail.com
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Job Reference ID:
5037071
Category:
Scientific
Duration:
Fulltime, Permanent
City, ST:
South San Francisco, California
Country:
United States |
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Description:
Director of Operations, GPRM
PRIMARY OBJECTIVE: Coordinating and performing the processing, and assisting in the collection and reporting of adverse events data in compliance with applicable FDA and global regulations and Elan Pharmaceuticals' Standard Operating Procedures (SOPs) and guidelines. Performing accurate computer data entry of identified AE information and ensuring the uniform and timely processing of adverse event reports. Coordinating the compilation of global and US aggregate reports. Participating in the set-up and maintenance of adverse event workflow, monitoring department policies and standard operating procedures. Coordinating the department's clerical workflow, and assisting with special projects. Acting as liaison with internal and external business partners to meet global regulatory reporting requirements and support other Elan business areas. Assisting with the preparation of internal and external reports. Operations Management staff are members of cross-functional teams and assist in the work of other GPRM groups as needed.
DUTIES/RESPONSIBILITIES: - Coordinates and participates in, as needed, the processing of adverse event information received by the GPRM department independently for assigned products, and assists in the preparation of internal and external reports. - Oversees writing of case narratives and writes case narratives, if needed. - Responsible for the review of adverse event information received by the GPRM department for completeness and consistency. - Coordinates the compilation of aggregate reports per US and international regulations independently. - Ensures compliance of adverse events data processing and the compilation of aggregate reports for assigned products with timelines according to US and international regulations and Elan Pharmaceuticals' SOPs guidelines. - Plans, directs, and is responsible for executing Operations Management Group projects independently. - Manages multiple Operations Management Group projects. - Participates in the creation of GPRM policies and procedures and standard operating procedures. - Mentors internal sources and participates in GPRM training initiatives. - Acts as a liaison with internal and external business partners on GPRM operations management issues. - Functional role as either a project manager (individual contributor) or supervise assigned staff.
EDUCATION/EXPERIENCE: PhD in Life Sciences and 3-5 years safety surveillance experience, MD preferred.
SKILLS/ABILITIES: - Knowledge of FDA and international adverse event reporting regulations per International Conference of Harmonization (ICH) Guidelines and the ability to interpret and apply applicable regulations to resolve issues. - Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with regulations. - Experience with preparation of investigational and postmarketing regulatory reports. - Proficiency with standard desktop computing programs, and relational databases. - Excellent oral and written communication skills. - Demonstrates consistent attention to detail. - Highly organized and understanding of workflow prioritization. - Project management experience is desirable. - Previous line management experience. - Support Global Head of GPRM and deputise for Global Head with internal and external customers.
Apply by eMail:do_not_reply@invalidemail.com
Job Created:
Tue Oct 06 2009 06:09:49 AM
Last Modified: Fri Nov 20 2009 06:16:57 AM
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