Total 7 job vacancies by 1G5 Pfizer Healthcare India Private Limited

Statistical Data Sciences & Analytics (SDSA) is a function within Global Biometrics & Data Management (GBDM), with the mission to predictably deliver and manage data as a strategic asset to the highest quality and regulatory standards. We are responsible for delivering timely and high quality Programming deliverables supporting Pfizer's portfolio, as well as excellence in the selection and application of algorithms, and establishment of advanced programming practices from study-level requirements through submission and product defense.
 
We are looking for students who are pursuing their final year Master's or M. Tech degree in Statistics/Biostatistics/Mathematics/Data Science/Bio-technology/Bio-Medical Engineering/Computers or IT Engineering to do this fixed-term internship with us for 4 months - April 2024 till July 2024.

  
Work Location: On Premise in Chennai

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

Position: Manager Aggregate Report Analyst

Location: Chennai

• The PSSR Aggregate Reports Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams.  These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc.), responses to regulatory queries on safety topics, post-marketing safety assessments, Risk Management Plans and relevant documents, and other documents in support of  safety changes to labeling documents. 
• Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission.  Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents.
• Assess document requirements, gauge document complexity, and identify information gaps or other potential issues.  In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues.
• Lead a team of internal or external (contractor) authors if multiple or complex documents are required for a particular project.
• Support WSR teams by providing analyses of post-marketing safety data, reviews of the medical literature, and similar related activities.

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

Intern recruitment

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

“ROLE SUMMARY
The Sr. Advisor will report into the PharmSci Learning and Development Operations Lead supporting both the BioTherapeutics Pharmaceutical Sciences (BTxPS) and Pharmaceutical Sciences Small Molecule (PSSM) organizations. The role will work within a team that is responsible for administering the Learning Management System (LMS) for PharmSci and managing, maintaining, implementing and continuously improving the systems, tools and automation services owned by PharmSci Learning and Development.
ROLE RESPONSIBILITIES
Role responsibilities include, but are not limited to, the following:
• Performs the role of a Training Point of Contact (TPoC): partners with procedure authors to perform training risk assessments, create training implementation plans, and develop training content.
• Performs the role of a Course Developer: develops electronic and/or extended reality learning and assessment modules using cutting edge technologies and instructional design principles for adult learners.
• Performs the role of a Registrar: supports curriculum management through assignment and removal of job codes to colleague training curricula and processing course completion data and waivers in the learning management system.
• Ensures the standards for training documentation completion and storage are upheld; facilitates corrections to incomplete or incorrect training documentation and seeks/pursues solutions to error-proof training documents.
• Partners with business lines to perform training risk assessments, create training implementation plans, and develop training content.
• Quality checks modifications to curricula made by other learning management administrators via the PharmSci Training Implementation Plan (TIP) and Request Hub tools.
• Assists with the development and delivery of training compliance reporting solutions.
• Generate ad-hoc and scheduled training report and troubleshoot reporting issues and other inquiries.
• Process ILT and OJT credit completions, waivers and assignment requests.
• Practices good stewardship of the PharmSci training and learning budget.
BASIC QUALIFICATIONS
• Bachelor’s Degree and a minimum of four years’ experience as an LMS Administrator, or equivalent experience.
• Outstanding problem solving, analytical, organizational and time management skills.
• Strong Microsoft Office skills.
• Understanding of adult learning concepts.
• Excellent verbal and written communications skills
• Demonstrated ability to work and collaborate cross-functionally and cross-culturally.
• Knowledge of and demonstrated experience with reports software, building queries, etc.
• Experience in one or more authoring tools
• Problem solver with attention to detail who is self-motivated.
• Supports a culture of continuous improvement in which performance is consistently measured against goals.
• Ability to manage and prioritize projects and time, and to work with the team or independently as needed.
• Ability to escalate and effectively resolve issues.

PREFERRED QUALIFICATIONS
• Experience working within Success Factors LMS
• Experience working with Articulate authoring tool
• Experience working within a regulated environment

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

Role Summary:

The role of Associate package design and development will be Designing of Packaging commodities specifications, bill of material, artworks etc. Design of packaging process for required product-packaging configurations. Technical support on Packaging process to Production-packing and cross functional teams, troubleshoot exercise on packaging commodities and process. The associate packaging engineer is expected to develop packaging configurations and to manage technical efforts. Must be capable of ensuring resolution of all technical issues and providing timely implementation of all projects to maintain a consistent supply of our products to the market, while maintaining compliance to cGMPs.

• Create and provided Material codes, Key Line drawings and dimensions to Labeling team for the commercial artwork’s developments.
• Change control initiation and track the impact assessment, Pre-approval, and closure of change on time.
• Create Artworks request for Plant based changes, coordinate with Market coordinator and site supply chain team for LOCD, artwork center and accept PAR.
• Creates editors copy, operational copy of artworks, inputs to PAR per market and plant requirements.
• Review and approval of artworks for the printed packaging component.
• Preparation of packaging component specifications (Secondary and tertiary packaging component), and bill of materials, batch records,
• Preparation and approval of Shipper/case labels artwork, pallet label artwork, batch packing records, Standard test Procedure related to Packaging component and process.
• Review and approval of print proof & specimen of printed packaging component specifications.
• Serialization Support to production packing team.
• Technical support to production-packing Team for smooth launching of products.
• Work on commodity localization project for Primary and Secondary Packaging component.
• Preparation, review, and approval machine trial protocol for packaging components.
• Preparation, review, and approval of material evaluation protocol for packaging components.
• Review and approval of PPAP documents.
• Prepare Quality Risk assessment documents.
• Work with operation team and identify improvement projects and implement the same at site.
• IMEX for Packaging line as Process centric team.
• Cost improvement projects.
• Support to production packing team for new equipment’s/ machinery.
• Coordinate with cross functional team such as Pfizer site operations, Supply chain, Procurement, Engineering, Regulatory Affairs, Validation and Quality Assurance team for smooth executions of the project.

Preferred Education/ Qualification:

B.Sc/ M.Sc/ BE/ PGD in Packaging Technology (Preferable from Indian Institute of Packaging)

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

ROLE SUMMARY

• Leverage technical AI/ML/data science to guide critical decision-making processes in support of scientific and drug development strategies.

• Implement AI/ML algorithms under the supervision of senior data scientists 

ROLE RESPONSIBILITIES

• Work closely with global and regional teams to apply AI/ML innovative solutions to business problems and deliver on improving efficiencies in areas of drug development, e.g. in drug discovery, clinical trials, operational efficiencies.
• Translate business requirements into tangible solution specifications and high quality, on time deliverables
• Effectively use tools to manipulate and create large-scale databases from internal and external sources, to enhance business use cases
• Support business process excellence by implementing, and under supervision creating new processes and pipelines

BASIC QUALIFICATIONS

• Postgraduate with at least one year of relevant business experience
• Python or R fluency
• Ability to contribute to an AI/ML/data science pipeline including the various steps of data retrieval, cleaning, analysis/modeling, application of AI algorithms through to production
• Familiarity with standard supervised and unsupervised machine learning approaches
• Eagerness and self-starter to leverage and apply the latest research to real problems
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.

PREFERRED QUALIFICATIONS

• Experience working in scalable computing would be a valuable supplement (AWS, Spark, Kubernetes, etc.)
• Experience in data visualization, user interfaces (Flask, Shiny, etc.), data pipelines and MLOps are a plus
• Knowledge of pharmaceutical area and chemistry/biology familiarity

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

Job responsibilities:

Carry out case processing activities

Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency.  Process cases based on these assessments

Review case criteria to determine appropriate workflow for case processing

Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately

Write and edit case narrative

Determine and perform appropriate case follow-up, including generation of follow-up requests

Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios

Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation

Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database

Determine reportability of scheduled reports, ensuring adherence to regulatory requirements

Consistently apply regulatory requirements and Pfizer policies

Participate, as appropriate, in local, internal and external safety activities.

Qualification & Experience:

B. Pharm./ M.Pharm. / Pharm D graduates with 2-3 years of experience in ICSR case processing

Must have:

• Meticulous attention to detail and accuracy

• Good written communication skills

• Analytical and problem-solving skills

• Proficient in medical terminology

• Knowledge of ICSR processing guidelines and regulations

Nice to have:

• Knowledge of event assessment

• Working experience in ARGUS database 

  
Work Location Assignment: On Premise

"All elements of your compensation including the value of non-monetary perquisites valued in accordance with the Income-tax Act, 1961 ('the Act'), shall be subject to deduction of applicable tax at source, as required to be deducted by the Company under the Act."

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