Safety Physician

Syneos Health; Hyderabad; On-site; INR 1,500,000 - 3,000,000; Full time

Job summary

Syneos Health in Hyderabad, India, seeks a Safety Physician to perform medical review of adverse events for investigational and marketed products. You will work with SPVG colleagues to ensure accurate interpretation and regulatory compliant reporting.

The role requires familiarity with safety databases like ARGUS and coding dictionaries such as MedDRA, with a focus on maintaining medical accuracy in ICSR narratives and aggregate safety reports.

Qualifications

• Medicine or clinical background preferred.
• Experience in safety data review is desirable.
• Familiarity with pharmacovigilance processes and regulatory expectations.

Responsibilities

• Performs medical review of adverse events for investigational and marketed products.
• Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS.
• Collaborates with SPVG to ensure accurate medical interpretation of adverse event cases.
• Ensures regulatory and SOP compliance for safety evaluation and reporting.
• Identifies and communicates potential safety issues promptly.
• Interacts with client safety/medical personnel as appropriate.
• Keeps abreast of clinical and drug development information relevant to programs.
• Provides medical review for aggregate safety reports (PSURs, PADERs, etc.).
• Maintains ongoing pharmacovigilance expertise through CME.
• Mentors and trains other internal safety staff.

Skills

Medical review

Pharmacovigilance

MedDRA

ARGUS

Tools

ARGUS Safety

MedDRA

Job description

Job Description:

Description

Safety Physician

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

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 deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job 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.

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.
http://www.syneoshealth.com

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.

Summary

The position is responsible for performing medical review of Individual Case Safety Reports (ICSRs), conducting medical assessement of all safety related data and ensuring medical accuracy of the ICSR narrative, coding and appropriate medical interpretation of all cases.

Requirements: