Careers

Positions Available

Senior Medical Writer

Location: Pune/Mumbai

Skills Required:

  • Master’s/Bachelor’s Degree in Life Science (B. Pharm, M. Pharm, Dentists) Biomedical Degree, or Nursing
  • Minimum of 3 years of PV experience (including minimum of 2 years of authoring and review of all sections of periodic safety reports including PBRERs, PSURs, DSURs, etc.)
  • 2 years of experience in RMP & Signal Management

Apply

Medical Writer

Location: Pune/Mumbai

Skills Required:

  • Master’s/Bachelor’s Degree in Life Science, Biomedical Degree, or Nursing
  • Minimum of 2-3 years of PV experience (including minimum of 2 years of authoring and review of all sections of periodic safety reports including PBRERs, PSURs, DSURs, etc.)
  • 1 year of experience in RMP and signal management

Apply

Safety Physician

Location: Pune/Mumbai

Responsibilities:

Reviewing of critical sections of periodic safety reports including PBRERs, PSURs, DSURs, etc. and Safety Assessment Reports, RMP and Signal Analysis.

Skills Required:

  • Medical graduate/post-graduate (MBBS/ MD)
  • Minimum 3 years of total PV experience.
  • Preferred with 2 Years of aggregate medical review experience

Apply

Safety Physician

Location: Manila, Philippines

Responsibilities:

  • Perform all medical-related aspects of drug safety management processes
  • Execute drug safety data management processes- perform medical case review, safety and medical assessment, case validation (medical coding, causality assessment, seriousness assessment, safety narrative writing)
  • Ensure that assigned medical deliverables meet expected quality and timelines

Skills Required:

  • Candidate must possess a professional license in Medicine (MD)
  • At least 3 years’ experience in a clinical practice settin
  • Technical proficiency with Microsoft Office Applications
  • Willing to work in Ortigas Center, Pasig City

Apply

Safety Nurse for Medical Review

Location: Manila, Philippines

Responsibilities:

  • Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness, causality, adverse event coding and narrative review.
  • Update and document daily case data, case-feedback in appropriate tools to facilitate tracking and workflow management
  • Assume complete responsibility for full assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs.

Skills Required:

  • Bachelor’s Degree or Master’s Degree in Nursing
  • Candidate must possess a professional license in Nursing (RN)
  • With hospital experience of two (2) years or more
  • Technical proficiency with Microsoft Office Applications
  • Willing to work in Ortigas Center, Pasig City

Apply

Contact Center Associate

Location: Bucharest, Romania

Number of Positions : 5
Languages required : English + German

Responsibilities:

  • Ability to receive and manage in-bound and out-bound calls
  • Attention to detail
  • Good verbal and written communication skills
  • Concern for quality
  • Analytical capabilities
  • Ability to analyze & synthesize medical information
  • Customer focus

Skills Required:

  • Bachelor’s or Masters in Pharmacy or Life Science or Medical Science or related area
  • Fresher to 2 years of experience in Pharmacovigilance or any Pharma industry is preferred
  • Voice Call Management
  • Pharmacovigilance
  • Preferable: Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH-GCP guidelines
  • Technical proficiency with Microsoft Office suite applications

Apply

(SCINMW01) Medical Writer – (Pune)

Location: 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

Apply

(SCINPV02) Safety Data Analyst – (Mumbai/Pune)

Location: Pune/Mumbai

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.

Apply

(SCINPV01) Safety Data Analyst – Voice – (Mumbai)

Location: 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.

Apply

(SCPVIN03) Safety Physician (Mumbai / Pune)

Location: Pune/Mumbai

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 Required:

  • 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

Apply