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Documentation Specialist II Documentation Specialist II
Ref No.: 17-14539
Location: Bridgewater, New Jersey
Under the supervision of the Global Lead of PV Standards and Training, the incumbent participates in the development, implementation and maintenance of a quality system related to the quality documents and conduct of appropriate training.
Main missions of the role are described below, regarding the two areas of activity:
Participate in the definition of GPE standards, to ensure the preparation and maintenance of Quality documents (QDs) and standards applicable for GPE and PV network in line with global quality directives and to ensure the delivery of training of the respective QDs - Ensure required or essential quality documents are authored in due time in collaboration with respective Subject Matter Experts (SMEs). - Maintain coordination with the Quality Document network and Training coordinators from other functions - Participate to the development of the global strategy of continuous training/education for all Pharmacovigilance associates (GPE, Affiliates). Oversee and support the development of training material for all associates regarding PV business needs - Work with managers across the Pharmacovigilance business to identify skill/training gaps, training opportunities and develop/deliver training solutions - Participate/Coordinate special projects like PV Awareness, launch of One LMS, Geode + deployment, QD & Training strategy for Aegis ,....

Knowledge And Skills
Strong analytical skill and developed insight for analysis of issues ensuring scientific rigor/good quality in all analyses and decision-making based on sound risk-based judgment Excellent writing and oral communication skills; Basic knowledge of training processes, curriculum management and adult learning theory. Strong interpersonal skills: interaction with individuals of various background such as various levels in other departments and other countries Ability to provide clear concise summary and identify key issues which are a concern for GPE. Ability to work independently and successfully manages multiple priorities simultaneously. Computer literacy (Microsoft Office). Good understanding of Quality Management System and their implementation In-depth knowledge of International Pharmacovigilance requirements, US FDA, EMEA requirements/international guidelines, ICH/CIOMS.

. Formal Education And Experience Required:
- Minimum experience 5 to 7 years in International Pharmacovigilance activities including case processing, involvement in interaction with affiliates, training users - Certified health professional degree preferred: example Pharmacist or Pharm D or Bachelor of nursing degree or Health Science degree required -Demonstrated Understanding of Pharmacovigilance processes, PV database system, Dictionaries required. - Knowledge of international regulations and guidelines ICH, CIOMS, EMEA/FDA.

To promote a single consistent approach in sanofi processes and facilitate compliance to PV requirement: - Create and maintain a list of required GPE/PV quality document. Ensure sanofi architecture of QD is applied. - Foster simplification and avoid redundancy of Quality Documents - Monitor adequacy of content of current Quality Documents and standard definition versus regulations and international guidelines; propose update or creation of new Quality Documents as appropriate. - Ensure that any regulatory requirement and distribution requirement to CSLs is possible with the current rules/process..
Ensure timeliness and quality of GPE Quality document in Quality Document Management System is a critical part of the job. - Ensure document are following the correct workflow - Review regularly workflow steps of each document until approved. Remind authors, reviewers and authorizer as needed. - Ensure QC step of each document
Coordinate and deliver regular training in Pharmacovigilance to GPE personnel including the PV network (Country PV units). Provide training and awareness to non PV personnel as needed Utilize a variety of instructional techniques and delivery methods, including classroom based learning, self-study, and technology-based learning Evaluate effectiveness of training by creating and implementing quizzes and tests
Contribute to the identification of skill/training gaps, training opportunities and develop/deliver training solutions
Controls that training plans & records for documenting, maintaining & developing the competences of personal are kept and made available for audit or inspection