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 Required
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.
(SCINPV02) Safety Data Analyst - (Mumbai/Pune)
Responsibilities
Execute drug safety data management processes - a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, call intake, case follow-up, report preparation and submission to regulatory authorities.
Perform any other support activities as assigned - tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources including literature search
Assume responsibility for quality of data processed
Skills Required
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.
(SCINMW01) 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 Required
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
(SCINSP01) Statistical Programmer - (Pune)
Responsibilities
Read study documents (Protocol, CRF, DORP, SAP)
Contribute to programming sections of Statistical Analysis Plans
Extract data using SAS
Skills Required
Post graduate degree in Statistics or Computer Science
2-4 years of experience as a SAS
Not finding the role you are looking for?
Leave us a word. We will get back to you in an opportune moment.