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Safety Physician

  • Job
    Full-time
    Junior Level
  • Science
    Healthcare
  • Hyderabad, +1

AI generated summary

  • You must have an M.D., D.O., or MBBS, a completed residency, 1-2 years clinical experience, 1 year in pharmacovigilance, regulatory knowledge, and strong communication skills.
  • You will review adverse event cases, ensure compliance, manage safety issues, collaborate with teams, provide medical insights for reports, mentor staff, and maintain medical expertise.

Requirements

  • The incumbent should possess M.D., MBBS, D.O.
  • Completed an accredited residency; Minimum of one to two (1 to 2) years of experience in clinical practice
  • Minimum of one year of experience in the pharmaceutical, biotechnology, or device industry working in pharmacovigilance/epidemiology preferred
  • Knowledge of global pharmacovigilance regulations and processes
  • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), safety databases, and internet.
  • Excellent verbal and written communication skills (proficient in English) as well as in the language required for case processing
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform and influence
  • Ability to travel as necessary (up to 10%)

Responsibilities

  • Performs medical review of adverse events reported for investigational and marketed products
  • Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS
  • Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment
  • Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information
  • Identifies, communicates and effectively manages potential safety issues
  • Interacts with client's safety/medical personnel as appropriate
  • Stays abreast of clinical and drug development information relevant to contracted programs
  • Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs)
  • Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education
  • Assists as a mentor and trainer for other internal safety staff including case processing staff
  • Responsible for performing activities that are in compliance with applicable Corporate and D Departmental Policies, Standard Operating Procedures, Work Instructions and any project specific Operating Guidelines
  • Performing other duties as assigned by management

FAQs

What is the role of a Safety Physician at Syneos Health?

The Safety Physician at Syneos Health performs medical reviews of adverse events, maintains familiarity with safety databases, ensures regulatory compliance, identifies potential safety issues, and provides medical interpretation for safety reports.

What qualifications are required for the Safety Physician position?

Candidates must possess an M.D., MBBS, or D.O., have completed an accredited residency, and have a minimum of 1-2 years of clinical practice experience. Experience in the pharmaceutical industry, particularly in pharmacovigilance, is preferred.

What are the key responsibilities of the Safety Physician?

Key responsibilities include reviewing adverse events, ensuring compliance with safety regulations, managing safety issues, and mentoring internal safety staff. They also provide medical review for aggregate safety reports.

Is prior experience in the pharmaceutical industry necessary?

While not mandatory, a minimum of one year of experience in the pharmaceutical, biotechnology, or device industry, particularly in pharmacovigilance/epidemiology, is preferred.

What software skills are necessary for this position?

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, safety databases, and email applications (Outlook) is required.

Are there opportunities for career development as a Safety Physician?

Yes, Syneos Health is committed to developing its employees through career progression, technical training, and peer recognition.

How important is communication skill for the Safety Physician role?

Excellent verbal and written communication skills are essential, as the role involves informing and influencing various stakeholders.

Is travel required for this position?

Yes, the role may require travel of up to 10%.

What is the work culture like at Syneos Health?

Syneos Health promotes a Total Self culture, emphasizing authenticity, diversity of thought, and a supportive environment where employees can thrive and feel a sense of belonging.

Does Syneos Health offer remote work options?

Yes, Syneos Health supports remote work, but typically in a hybrid format.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Syneos Health® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.