Sr Safety Physician

Sr Safety Physician

inVentiv Health Clinical SRE, LLC
Not Specified
Not Specified

Job Description


Job Description :
Senior Safety Physician
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
. #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
. We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job responsibilities
. 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. Qualifications
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 three (3) to five (5) years 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 informand influence
. Ability to travel as necessary (up to 10%)
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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