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Project Manager in Drug and Safety Enviroment

Company Name:
Randstad Technologies
SUMMARY
(State the major objective of your
position
.)

Manage the production of ad hoc queries of Argus Safety.
Manage the generation of DSP ancillary reports utilized during regulatory data analysis for completing the ICH PSUR for submission.
Manage the implementations of new and versioned DSP systems.
Produce SQL and related documentation as required.
Manage the administration of all DSP systems.


PRINCIPAL ACCOUNTABILITIES
(Describe in a series of brief statements up to five of your primary
job
responsibilities or activities in descending order of importance.)

Master and maintain up-to-date knowledge of the US Federal Regulations and Guidelines governing the reporting of investigational and postmarketing adverse
events
.
Master and maintain knowledge of the ICH regulations and guidelines governing the global reporting of adverse events on investigational and/or marketed products (particularly ICH E2A, E2C and E2B).
Master navigating through the ARGUS Safety Database including all details of its configuration.
Programming, validation and generation of US periodic reports, ICH PSUR line listings and ancillary reports to support data analysis.
Design and generation of ad-hoc reports to support queries from regulatory authorities (domestic and foreign), Purdue's Law Department, healthcare professionals and/or as requested by your immediate
supervisor
or the
executive
Medical Director, Drug Safety and Pharmacovigilance.
Manage Implementations of new and versioned DSP systems.
Provide operational support for all existing and future drug safety systems (Argus Safety, SWIFT, Empirica Signal).
Master the MedDRA principles and hierarchy and the regulations and guidelines to assist in the conversion of legacy data and the implementation of MedDRA into the Argus Safety application. Plan dictionary upgrades and versions management.
Assist in management and administration of international adverse event database: Quality control monitoring, administration of user accounts, dictionary maintenance, configuration management, providing user support (with referral to IT when necessary).
Act as a DSP Systems liaison with the IT Department.
Interact with internal and external groups on drug safety operations issues, when necessary.
Assist in other departmental tasks, as assigned by your immediate supervisor or the Executive Medical Director, Drug Safety and Pharmacovigilance, to ensure Purdue's compliance with all FDA and ICH regulations and guidelines governing the reporting of adverse events and product complaints.



JOB SPECIFICATIONS QUESTIONNAIRE

1. KNOWLEDGE
Describe the specific knowledge required to perform the job. Indicate why each component is necessary to successful job performance. Consider understanding of facts, theories, terminology, concepts, disciplines, processes, or techniques used on the job. Describe formal academic, vocational, or on-the-job training, self-education; progressive work experience required.

Minimum BS or equivalent in technical field required. Concentration in
computer
Science or Information technology fields is preferred.
Minimum 4 years of experience within pharmaceutical industry required, including 4 years of experience with drug safety systems and applications
Advanced understanding of FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs
Advanced understanding of ICH guidelines
Working understanding of MedDRA structure
Very good knowledge of Oracle databases and SQL/PLSQL programming
Advanced understanding and application of guidelines detailed in 21 CFR Part 11, including system validation requirements
Very good knowledge of report generation using Cognos and Crystal
Personnel management, including recruiting, coaching and training, evaluating performance, providing feedback, development planning
Working understanding of Argus Safety Database
Knowledge of Safety Signal detection and Data Mining is a preferred
Proficiency with basic MS Office applications. Advanced Microsoft excel skills is preferred.
Working knowledge of scientific terms and medical terminology
Written and verbal communication skills; interpersonal skills
Organization skills
Analytical skills
Product knowledge
Time mgmt and ability to prioritize workload (self, others)
Quality orientation: attention to detail, accuracy
Advanced understanding of safety processes
Understanding of training concepts
Ability to influence others
Project management skills
Meeting facilitation
Basic understanding of documentation requirements in a regulated environment
Basic knowledge of regulatory dossier and controlled document applications



2. PROBLEM COMPLEXITY
Describe the "thinking challenge" of the job: the nature of the problems to be solved and data interpreted; the extent to which originality, innovation, and creativity are required. Consider the nature of the work itself, variety of assignments, availability of guidance and direction, the scope of tasks, and the time frame under consideration.

Expertise to (1) engineer the validation of a new system or a change to an existing system that is compliant to 21 CFR Part 11 and (2) engineer SQL query to respond to a formal request.
Expertise is expected to be leveraged by DSP colleagues for data analysis of regulatory purposes, such as generating an ICH PSUR, as well as maintaining the validated state of all DSP systems.
Be able to supervise staff providing validation and/or query support, to maintain consistent standards and adhere to departmental procedures.
A thorough understanding of configuration of all safety systems and how these function is necessary. Compliance with Regulatory requirements must receive the highest consideration and priority.



3. FREEDOM TO ACT
Describe the discretionary authority of the job and the direction exercised over it. Consider its role in establishing and/or affecting organizational goals, policies, and procedures. Include restrains imposed by internal written instructions, policies, or procedures, and external laws and regulations. Consider time frame of work objectives, task diversity, and initiative expected, permitted or required.

Incumbent has some latitude of freedom to plan and prioritize time frame of work objectives for his/herself as long as these are in line with the departmental business objectives and project timelines. Some degree of independence is encouraged, although, assistance from colleagues in the Drug Safety and Pharmacovigilance Department is strongly recommended particularly from the Drug Safety Systems group.


4. IMPACT
Describe the impact of the position on company, work unit, or product line results. Consider impact in terms of financial input/output (revenues, expenses, assets, budget) and human resources (organizational span of control). Indicate the importance of errors, if made, the likelihood of error, and a cost associated with correcting those errors.


Ensures that work activities within area of responsibility and partner organizations remain aligned with overall departmental and business objectives; decisions can have a significant impact on expenditure or time and resources across multiple departments
Inaccurate, incomplete or late reporting of post-marketing adverse events to the FDA could result in action on part of the FDA, i.e. a 483 warning letter, which could in turn negatively impact on Purdue's professional image

5. SUPERVISORY RELATIONSHIP/DIRECT WORK INVOLVEMENT
Explain the supervisory responsibilities of the job. Consider the depth of the supervisory chain of command, both above and below the position, the nature of the work force directed, and the nature of the work itself. To what extent does the incumbent perform duties similar to those of superiors or subordinates?

Supervision from the Assoc. Director, Drug Safety Systems is required on many system, workflow, and regulatory issues.
Incumbent is expected to indirectly supervise other staff as well as consultants when managing projects.




6. LIAISON
Describe the job requirements for communicating effectively with others, inside and outside the company. Keep in mind the nature of the communication, ranging form uncomplicated exchanges of information up to complicated discussions and negotiations. Describe the significance, purpose, and frequency of contacts, and their potential impact on company operations and good will.

Frequent interaction is required with domestic and international drug safety personnel, as well as with personnel in the IT Department.

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