(SCINPV01) Safety Data Analyst - Voice - (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 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