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Process Analyst


Milan, TN 38358
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Job Details

**Position Purpose**

The Process Analyst will be responsible for managing product-related and non-product projects to support the Worldwide Safety (WWS) department primarily the SSRM BUs, but also other groups within WWS as appropriate. The PA will be responsible for supporting both novel and routine SSRM and Safety processes, within and across DAs, Safety Lines and BU/RUs. The PA independently performance manages processes, compliance, and performance metrics. With experience the PA will act as a consultant on relevant WWS processes and SOPs to Product teams. Experienced PAs may coach or mentor more junior PAs.

PAs' can be assigned to RMPL responsibilities in accordance to their level within the role as defined in this Job Description.

**Primary Responsibilities**

+ Facilitate Risk Management Committee (RMC) and Benefit Risk Committee (BRC) meetings. This includes, but is not limited to, ensuring that the meeting happens in line with the relevant SOPs, making sure the correct personnel attend the meeting, issuing agendas prior to the meeting and minutes and actions after the meeting in a timely fashion. The PA at this level must have a good understanding of the relevant SOPs to help guide the SRLs and clinical teams for their Drug Products.

+ Applies leadership, analytical skills, and process and project management support to DA areas, including RMCs and SR-CWGs, REMS and RMP Core Working Groups. Builds appropriate agendas, provides draft and final minutes and drives the actions to completion. Responsible for the storage and tracking of safety action items from meetings.

+ Implements opportunities identified for consistency and standardization in Safety.

+ Provides support for internal and external audits/inspections relating to safety, ensuring timely provision of responses to inquiries raised by inspectors/auditors.

+ Supports managing the Safety Signal and Risk Management System:

+ Incumbent is responsible for leading and facilitating the activities of SSRM (which involves SSRM's identification and evaluation of safety signals, decision-making regarding action to be taken in response to those signals, and generation of safety-related documents).

+ Monitors and tracks acute safety concerns arising from SSRM safety surveillance and risk management activities in DAs/BUs. Ensures timelines and processes are followed and communicated to applicable groups. Identifies and evaluates issues and presents strategies to ensure that timelines are met or accelerated.

+ Works with SRLs to ensure product Safety Review Planning is in place and progressing.

+ Manages projects from Safety Strategy engaging Clinical-Safety interactions such as safety data surfacing (for example, Safety First Group, Business Technology, Metrics monitoring meetings)

+ Designs and oversees the tracking of applicable Safety metrics. Regularly review and develop Policies and Procedures pertaining to SSRM and Safety functions as well as ensuring compliance with these procedures. In this regard, collaborates with other Safety Sciences Research functions, supports interface with WSRO on behalf of Safety. Where needed, supports WWS development of Service Level Agreements with BUs/RUs.

+ Provides guidance and coaching to less experienced PAs, participates in initial training of newly hired PAs, acts as first point of contact to assist other PAs in issue resolution.

+ In addition to the core functions, the PA will assist in inspection preparations, managing small non-drug product projects (such as process improvement initiatives) as well as documentation and tracking of Safety related activities

+ They will be responsible for good document management, such as archiving to GDMS the Safety strategy documents and archiving relevant safety documents to the PTMF

+ Assist the RMPL with the tracking of aRMMs in RMPs


B.S., M.S. in health science with significant advanced training, Pharm.D, or Ph.D, or equivalents. Knowledge of pharmacovigilance. Familiarity with management of performance metrics is desirable. Additionally, for PAs whose responsibilities include RMPL activities, preferred qualifications include: matrix project management, medical, clinical and lifecycle R&D training and/or experience.

Effective process analytical skills - Detail oriented, independent, and manage processes to both establish timelines and ensure timelines are met. Excellent organizational skills.

Computer applications - The PA should be competent in basic office computer applications such as MS Word, Excel, & PowerPoint, document management systems such as SharePoint and Documentum (GDMS) or similar, Meeting collaboration tools such as Outlook, WebEx or Similar, as well as department systems.

Fluent English

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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