Logo of Huzzle

Safety Physician

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

AI generated summary

  • You must have an M.D./MBBS/D.O., clinical practice experience, knowledge of pharmacovigilance, and strong communication skills. Proficient in MS Office and willing to travel up to 10%.
  • You will review adverse events, ensure regulatory compliance, manage safety issues, produce aggregate safety reports, and mentor staff while staying updated on drug development information.

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 performs medical reviews of adverse events for investigational and marketed products, ensures regulatory compliance, identifies potential safety issues, and provides medical interpretations for safety reports.

What qualifications are required for the Safety Physician position?

The incumbent should possess an M.D., MBBS, or D.O., and have completed an accredited residency along with a minimum of one to two years of clinical practice experience. Experience in the pharmaceutical or biotechnology industry is preferred.

Is experience in pharmacovigilance necessary for this role?

Yes, a minimum of one year of experience in pharmacovigilance or epidemiology is preferred for the Safety Physician position.

What kind of training or education is provided to employees?

Syneos Health is committed to developing its employees through career development, technical training, and therapeutic area training, along with a peer recognition program.

What are the primary responsibilities of a Safety Physician?

Responsibilities include medical review of adverse events, maintaining familiarity with safety databases, collaborating with colleagues in pharmacovigilance, ensuring compliance with regulations, and mentoring internal safety staff.

Is proficiency in Microsoft Office required for this position?

Yes, proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), along with knowledge of safety databases and email management, is required.

Are there language requirements for this role?

Yes, excellent verbal and written communication skills in English and the language required for case processing are essential.

How often will the Safety Physician need to travel?

The Safety Physician may need to travel as necessary, up to 10% of the time.

What is the company's culture like?

Syneos Health fosters a Total Self culture, encouraging employees to authentically be themselves, and promoting a diverse environment where everyone feels they belong.

Is previous experience in the biopharmaceutical industry mandatory?

While not mandatory, having at least one year of experience in the pharmaceutical, biotechnology, or device industry is preferred for this role.

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.