Medical Safety Physician

3 hours ago

india, IN Qinecsa Solutions Full time

We are Hiring Medical Safety Physicians/Drug Safety Physicians with 1-3 years of relevant experience as a Medical Reviewer.


Job Title: Medical Safety Physician

Qualifications

Education: MBBS / MD

Mandatory: MCI Registration/State Medical Council Registration

Experience: 1 - 3 years in Pharmacovigilance


Primary Responsibilities


As a medical reviewer


  • Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
  • Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
  • Perform triage of cases and determine seriousness and relatedness across products as assigned
  • Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
  • Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
  • Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
  • Conduct assessment of litigation cases across products as assigned
  • Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
  • Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
  • Acquire and maintain knowledge of applicable Global Health Authority regulations
  • Perform any other drug safety related activities as assigned.


Specialized knowledge and skills:

  • Experience with relevant safety databases and related software applications
  • Proven experience in customer handling and relationship.
  • Proven ability to perform task management.
  • Proven people management skills.
  • Must have good presentation skills and the ability to give presentations.
  • Knowledge of the Life Sciences Industry and life cycle of drug.
  • Relevant product and industry knowledge.


Secondary Responsibilities

  • strong competence with medical and therapeutic terminology
  • Understanding of Patient Safety regulatory obligation
  • Good attention to detail
  • Ability to deliver within established timelines
  • Fluency in Spoken and written English and excellent comprehension.


Additional Skills:

  • Strong motivational skills and abilities, promoting a team-based approach
  • Strong interpersonal and communication skills, both verbal and written
  • Strong organizational and leadership skills
  • Goal-oriented
  • Ability to maintain professional and positive attitude

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