Sr Safety Physician

**Description**

**Senior Safety Physician**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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 Full-Service 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 29,000 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 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
- 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**
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 73,000 Sites and 675,000+ 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 ever-changing 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