Job: Medical Writer at Sciformix, Pune/Mumbai

Vacancies for Medical Writer, Publishing Specialist, Safety Physician, Statistical Programmer, Safety Data Analyst at Sciformix, Pune and Mumbai

 

Medical Writer (Pune)

 

Responsibilities

  • Write various safety reports (or part of such reports) for global regulatory submissions for Sciformix’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports
  • Write Investigator brochures and sections of protocols
  • Write Clinical Study Reports (in whole or in part) for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses
  • Assist pharmacovigilance teams in writing narratives for the adverse drug reactions and adverse events they process
  • Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
  • Ensure compliance of operations with governing regulatory requirements

Skills

  • Master’s degree in Pharmacy/related science area with at least 2 years of experience in the pharmaceutical industry
  • Strong working knowledge of anatomy, physiology, disease states, medical treatments and procedures, medication names and drug therapy
  • Thorough understanding of drug safety
  • Orientation to pharmacokinetic and pharmacodynamic principles
  • Strong written and verbal language skills
  • Ability to analyze and synthesize medical information
  • Basic understanding of statistical concepts
  • Concern for quality, detail orientation

 

[btn text=”Click Here for more details” tcolor=#FFF thovercolor=#FFF link=”http://www.sciformix.com/careers/positions-available/” target=”_blank”]

 

 

Publishing Specialist (Mumbai / Pune)

 

Responsibilities

  • Electronic publishing of the following complex regulatory dossier and document types:  INDs, NDAs, CTDs, ANDAs, 510Ks, DMFs, IMPDs, Annual Reports, Amendments, Orphan Drug Designation Requests, Clinical Study Reports, Investigator Brochures, Clinical Protocols, Case Report Forms, SOPs
  • Utilization of a variety of software for complex regulatory document and dossier publishing including, but not limited to:  MSWord, Adobe Acrobat Professional, AutopageX Adobe plug-in, InSight Publisher, S-Cubed, CoreDossier, Image Solutions, Inc., (ISI) ISIToolBox Pharma Edition, ISIWriter templates, ISI eCTDXPress, ISIPublisher
  • Utilization of publishing equipment such as Docutech, scanners, printers, and copiers to compile and assemble paper regulatory documents and dossiers
  • Perform additional duties as assigned by the manager

Skills

  • Bachelor’s/Masters in Pharmacy or related science degree, or equivalent qualification
  • Desirable: 2-4 years of pharmaceutical experience in regulatory publishing

 

[btn text=”Click Here for more details” tcolor=#FFF thovercolor=#FFF link=”http://www.sciformix.com/careers/positions-available/” target=”_blank”]

 

 

Safety Data Analyst (Mumbai)

 

Responsibilities

  • To respond to medical information queries as per SOP such as request for product leaflet, information provided in product monographs and package inserts
  • To receive information and record Adverse Drug Reaction reports over telephonic call on the Telephone ADR Form.
  • Perform follow-up on cases by phone and record any specific follow-up information requested by the Safety Data Analysts
  • Respond to any product quality complaint as per SOP
  • Assume responsibility for quality of medical data recorded and collected

Skills

  • Bachelor’s in Pharmacy or related science with at least 2 years of experience, or Bachelor’s in Medical Science or related area, or Master’s in Pharmacy or related area
  • At least 1 year experience in pharmaceutical product development (formulation development, Phase 1-4 development, Regulatory affairs etc.).
  • Good oral and written communication skills
  • Understanding of global regulatory requirements
  • Ability to work independently with minimal supervision, yet should be a good team player
  • Knowledge of IT tools used in scientific data management, such as Oracle AERS, Relsys, ArisG, SAS, or others.

[btn text=”Click Here for more details” tcolor=#FFF thovercolor=#FFF link=”http://www.sciformix.com/careers/positions-available/” target=”_blank”]

 

 

Document Specialist (Mumbai / Pune)

 

Responsibilities

  • Responsible for the assembly, QC, and publishing readiness of all components of a document or submission package
  • Create and review submission tracking spreadsheet
  • Coordinate with authors to ensure submission timelines are met
  • Mediate between biostatistics/programming and the publishing functions to resolve issue related to document format (numbering, ordering, stapling program, etc)
  • Formatting  of documents
  • Ensure documents are ready for publishing
  • Create submission virtual documents (vDocs) and link all submission components to vDocs
  • Create submission tracking tool to ensure all components of submission are processed
  • Complete the appendices of clinical study reports and other regulatory documents by coordinating their delivery with other cross-functional groups
  • Quality Check Submission Output
  • Perform additional duties as assigned by the manager

 

Skills

  • Bachelor’s/Masters in Pharmacy or related science degree, or equivalent qualification
  • Desirable: 2-4 years of experience in regulatory document formatting and ensuring publishing readiness of documents

 

[btn text=”Click Here for more details” tcolor=#FFF thovercolor=#FFF link=”http://www.sciformix.com/careers/positions-available/” target=”_blank”]

 

 

Safety Physician (Mumbai / Pune)

 

 

Responsibilities

  • Execute drug safety data management processes – case review, safety and medical assessment, case validation (medical coding, causality assessment, seriousness assessment, safety narrative writing)
  • Write periodic safety reports and aggregate reports, including creation of case listings, population of generic parts of the report, review of literature search, label assessment and determination of exposure; review PSURs and Aggregate reports from a medical viewpoint
  • Provide training and guidance to process associates on medical aspects of case processing
  • Assume responsibility for quality of data processed

Skills

  • Clinical research & pharmacovigilance
  • Good understanding of regulatory requirements and ICH-GCP guidelines
  • Technical proficiency with Microsoft Office suite of applications
  • Expertise in medical review including deep understanding of applicable processes/standards
  • Ability to review, analyze & synthesize medical information
  • Highly focused on quality and timelines for medical deliverables
  • Good oral and written communication skills

 

[btn text=”Click Here for more details” tcolor=#FFF thovercolor=#FFF link=”http://www.sciformix.com/careers/positions-available/” target=”_blank”]

 

 

Experienced Statistical Programmer (Pune/Mumbai/US/UK)

 

Responsibilities

Contribute to programming sections of Statistical Analysis Plans
• Contribute to development of mock shells
• Develop specifications for analysis dataset (ADS)
• Create and validate ADS and Tables, Listings and graphs (TLGs) for analyzing safety data
• Create and validate ADS and Tables, Listings and graphs (TLGs) for analyzing efficacy data
• Perform quality control checks for TLGs (standard, non-standard and efficacy)
• Contribute in the blinded data review meetings
• Create patient profiles
• Support programming activities for ad-hoc/exploratory analysis
• Lead studies and manage teams as per experience

Skills

  • Post graduate degree in Statistics or Computer Science
    • Experience as a SAS programmer in the area of clinical trials
    • Thorough understanding of drug safety
    • Good understanding of clinical research and good clinical practices
    • Strong analytical thinking, problem solving capabilities
    • Good planning, prioritization and time management skills
    • Focus on quality deliverables to customers (internal and external)
    • Good written and oral communication skills

 

[btn text=”Click Here for more details” tcolor=#FFF thovercolor=#FFF link=”http://www.sciformix.com/careers/positions-available/” target=”_blank”]

 

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1 responses on "Job: Medical Writer at Sciformix, Pune/Mumbai"

  1. If Jobs in pv …let me knw

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