Syneos Health Hiring Sr Safety Physician – Aggregate Reports
16 April, 2022
- Performs medical review of adverse events reported for both 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)
- Participates in medical safety surveillance/signal detection benefit/risk assessment, and development of trend analyses
- Participates in the development of REMS and RMP as required
- Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education (CME)
- Serves as a mentor for other internal safety staff including case processing staff
- Supports business development activities as required
- Responsible for performing activities that are in compliance with applicable Corporate Policies, Standard Operating Procedures, Work Instructions and project specific Operating Guidelines
- Performing other duties as assigned by management.
What we’re looking for
- 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 2+ years of experience in Aggregate Reports, 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 informand influence
- Ability to travel as necessary (up to 10%)
Apply through this Link