World Wide Clinical Trials
Published
January 11, 2022
Location
United States
Category
Other  
Job Type
Work Setting
Remote / Home-based

Description

The Pharmacovigilance Physician is responsible for providing medical and scientific support to the Pharmacovigilance department in accordance with applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs), and project-specific instructions.

Primary responsibilities include regulatory assessment of reported serious adverse events, medical review of serious adverse events, medical training of PV staff and/or team, and safety surveillance and signal detection/analysis.

Responsibilities

Tasks may include but are not limited to:

  • Accountable and responsible for the medical review, analysis, and approval of all individual Serious Adverse Event and Serious Adverse Reaction reports
  • Provide guidance during the case handling and reporting cycle
  • Determine seriousness, causality, and summarize Sponsor position for single case reports
  • Perform analysis of similar events
  • Lead the preparation of aggregate safety reports (DSURs), case narratives, and any other safety medical documentation thus contributing to high-quality standard documents within the organization
  • Carry out continuous efficient evaluation of adverse events and all other safety information to predict and manage the safety profile of compounds in clinical development through identifying the need for updates to the reference safety information and drive proactive implementation of risk management initiatives in accordance with global regulatory requirements
  • Provide medical guidance and training to Drug Safety Associates in medical aspects of drug safety as well as to Medical Monitoring teams
  • Provide medical advice and support for the Pharmacovigilance component of feasibility studies
  • Inform the appropriate Medical Monitor of any new SUSAR or medically significant new information that might impact the safety profile of the medicine
  • Liaise with Medical Monitoring teams in projects requiring drug safety and medical monitoring services ensuring safety information is characterized and managed
  • Work with Business Development staff to assist in the acquisition of new work
  • May participate in business development activities such as presenting at conferences, participating in marketing efforts, authoring white papers, etc.
  • Maintain knowledge and understanding of safety-related regulations and guidelines
  • Maintain a basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope
  • Perform other duties as assigned.

Other Skills and Abilities

  • Strong understanding of serious adverse event medical review, assessment, and reporting process
  • Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment
  • Excellent organization skills and ability to handle multiple competing priorities within tight timelines
  • Consistently demonstrates commitment, dependability, cooperation, adaptability, and flexibility in executing daily tasks and responsibilities
  • Ability to anticipate needs and follow through on all assigned tasks
  • Able to effectively receive and provide constructive feedback without becoming defensive
  • Able to work well independently, but also able to seek input effectively from others when appropriate. Makes sound decisions within the scope of responsibility. Focuses on solutions and problem resolution verses complaining or placing blame

Requirements

  • Medical Degree from an accredited institution of Medical Education
  • Minimum of 3 years clinical research or industry experience with at least 2 years of experience serving as a PV Physician
  • Equivalent combination of relevant education and experience.
  • Excellent written and verbal communication skills
  • Excellent organization skills and attention to detail
  • Excellent presentation skills
  • Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines.
  • Ability to work independently, prioritize work effectively and work successfully in a matrix team environment
  • Ability and willingness to travel domestically and internationally if needed to support project meetings, bid defenses, and/or provide support for business development efforts
  • Fluent in written and verbal English
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