Job For B Pharma as Pharmacometrics Sr. Associate at Pfizer
Sr. Associate – Pharmacometrics
Job Summary
- Primarily responsible for liaising with Pharmacometrics (MBMA group) and clinical pharmacology therapeutic area leads in creating and maintaining up-to-date clinical literature databases and to provide data summaries and visualizations for clinical team reviews.
- Review data-request forms (PICOS), create literature searches and conduct manual as well as automated data extraction from scientific literature, conference abstracts, clinical databases etc., to generate curated data file (CDF) and development of a knowledge base for disease/therapeutic area,
- Document and report the effectiveness of the quality control checks and remediation performed and develop, maintain and report outcome of quality control metrics to demonstrate data curation and dataset construction quality improvement and maintenance goals and include the QC Form, QC Checklist, and QC Logs documentation on an indication-by-indication basis for each Final Draft
- May help provide support for creation and derivation of analysis-ready data sets, , conduct exploratory data analysis and visualization of literature and internal data to provide actionable insights to clinical teams to influence clinical trial design and decision making. May also help provide support for other pharmacometrics modeling such as population modeling, exposure-response modeling, model based meta-analysis (MBMA), quantitative methodology and best practices, pharmacometrics tools, software, hardware, and related business processes.
Job Responsibilities
- Responsible for interfacing with partner lines (e.g. clinical assay group, statistics, pharmacometrics) to ensure appropriate support for assigned programs and studies
- Curate data from the Public Literature and Pfizer internal sources as necessary based upon the Pfizer Model Based Meta-Analysis (MBMA) Data Definition for assembly of CDFs.
- Enhanced data extraction includes: Digitization of plots and Simple specified derivations
- Perform quality control checks on 100% of the curated data prior to final CDF delivery
- Identify and implement quality measures and systems.
- Create and provide mock/draft/sample CDFs and summary documentation to tabular and graphical presentations for review and comment by disease area team.
- Develop and generate Endpoint and Endpoint Subscale dictionaries producing a harmonized database of Endpoint Subscales in consultation with the MBMA Coordinator, maintaining the dictionaries in the approved MBMA repository. May contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships.
- Upon completion of provided training, conducts other pharmacometrics analysis such as population modeling and analysis, exposure-response analysis, model based meta-analysis (MBMA) clinical trial simulations and other analysis required to support clinical teams.
- Stays abreast of literature, government guidelines, and internal guidance as relates to modeling analysis including internal SOPs and regulations in order to be a team resource of pharmacometrics knowledge and applications.
Basic Qualifications:
- Bachelor’s in pharmacy (B.Pharm), Science (B.Sc), Technology (B.Tech), Pharmaceutical Sciences or related disciplines with 0-4 years of experience (for Associate position), 3-4 years of experience (for Sr. Associate position) in quantitative data analysis skills, or Masters in above disciplines with 0-3 years of experience (Sr. Associate position) in quantitative data analysis.
- Some experience with programming language any of the languages such as R (preferred), SAS, MATLAB, C/C++ or Python is required. Must be quantitatively inclined.
- Knowledge of Statistics, Drug-development will be preferred. Must be interested to work with clinical, medical and biological information.
- Good communication skills (written, oral presentation)
Preferred Qualifications:
- Other relevant software experience (e.g. Microsoft Excel and Word)
- We encourage applicants from different disciplines including clinical pharmacology, engineering, biostatistics, medicine, biology, etc.
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
GSK hiring FLL laboratory , B.Pharm & M Pharm GSK
Job description
Site Name: India – Maharashtra – Nashik Site
Posted Date: Jul 13 2023
Ready to help shape the future of healthcare?
Uniting science, technology, and talent to get ahead of disease together
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Job Purpose
He/She is accountable for the following activities;
- SLIMS Deployment and support for SLIMS operations at all sections of QC labrotory .
- Support to the production department to meet the manufacturing schedules by timely release of Raw materials/packaging material/ finished products/Bulk testing/Stability testing.
- GLP compliance, internal audits, Lab Investigations, Lab Safety, EHS, and Risk management related to Quality department and Values & expectation of the Organization.
Key Responsibilities
- To ensure adequate QC support to smooth implementation of SLIMS at site.
- Ensure sampling, testing, reporting and release of Raw materials/packaging material/ finished products/Bulk testing/Stability testing.
- All related QC RMS,SOPs, PQS preparation and review to meets all regulatory and QMS requirements
- Carrying out the gap analysis and compliance as per the ATS,CAP, GQP and GQMP
- Control on UK reference standard management require for QC laboratory
- Follow GMP & GLP as per schedule M & L.
- Ensure training of staff in sectional activities.
- Conduct L1/L2 audit as per the schedule.
- To ensure compliance to Safety in QC areas of operation
- Ensure compliance to GPS principles (LSW, Gemba,3Z etc)
- Coaching/counseling of staff for adherence to standards related to safety, quality & delivery. .
- Coordination & monitoring of dept consumables & inventory.
- Reduction in the cGMP noncompliance coming from L1/L2/L3/L4 audits & WHO audits.
- Handling of electronic systems (e.g. Empower,MERP, VQD, VQMS, SLIMS etc.)
- Handling of incidence,deviation,OOS,and CAPA management.
- Control and maintenance of documents including the quality systems as per the requirement of regulatory authorities which involves all raw data, SOPs, documentation exhibits, Protocols, training.
- To ensure instrumental audit trail program reviewed and documented periodically.
- Review of all analytical reports.
- To ensure the QC personnel completed the OJT/Analyst Qualification /My Learning modules and QMS training in time.
- Support the functional head to establish the activities assigned or identified “as and when basis”.
Scope of Accountability
He leverage his expertise for testing and reporting related activity of QC laboratory at Nashik Site.
- People Management.
- People engagement
- Attendance management.
- Weekly Schedule Delivery (CTP).
- Encourage people to raise Gemba Kaizen.
- Effectively utilization of GPS tools as day to day ways of working.
- Level 1 audit completion & closure of deviations in 25 days.
- Completion of safety incidence investigation in 10 days.
- No open ZAP> 90 days pending for closure.
Knowledge/ Education / Experience Required
A. Educational Background
M.Sc /B.Pharm/ M.Pharm (Science Graduate/post Graduate)
Area of Specialisation : Science/Pharmacy
B. Job-Related Experience
5+ years expirence in Pharmaceutical Plant
C. Other Job-Related Skills/Background
- Advanced knowledge of computer software & potency in use of computer software (Word, Excel, Powe Point).
- Resource Planning
- Problem Solving
- Effective communication skills
- Ability to build relationships (Team building ) at all levels and across functions.
- Have Influencing skilled & IR issue handling.
At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
*LI-GSK
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.
GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.
If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.