Syneos Health® is a leading 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.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a FullService environment you’ll collaborate with passionate problem solvers innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives.
Discover what our 29000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally and we are dedicated to taking care of our people.
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 investigational and marketed products
Maintains familiarity with MedDRA WHODRL 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 postmarketing 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.
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 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%)
Get to know Syneos Health
Over the past 5 years we have worked with 94% of all Novel FDA Approved Drugs 95% of EMA Authorized Products and over 200 Studies across 73000 Sites and 675000 Trial patients.
No matter what your role is you’ll take the initiative and challenge the status quo with us in a highly competitive and everchanging environment. 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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