Description
Safety & PV Specialist I - Medical Device & PQC
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
ob Responsibilities
Location: Hyderabad, India (Office-Based)
Employment Type: Full-Time
Experience Required: 2.5 – 4 Years
The Safety & Pharmacovigilance Specialist I is responsible for end-to-end ICSR processing, safety data management, regulatory reporting support, and compliance with global pharmacovigilance regulations. The role requires demonstrated expertise in Product Quality Complaint (PQC) case handling and experience in medical research safety cases.
Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
Process ICSRs in accordance with Standard Operating Procedures (SOPs) and project/program-specific safety plans.
Triage ICSRs and evaluate case data for completeness, accuracy, and regulatory reportability.
Enter case data into the safety database (Argus / ARISg).
Code adverse events, medical history, concomitant medications, and laboratory tests using MedDRA and relevant dictionaries.
Prepare comprehensive and medically accurate narrative summaries.
Identify missing or inconsistent information and follow up on queries until satisfactory resolution.
Identify and manage duplicate ICSRs.
Perform quality review of ICSRs.
Assist in the preparation and submission of timely, consistent, and accurate expedited safety reports in accordance with global regulatory requirements.
Validate and submit xEVMPD product records, including appropriate MedDRA coding of indication terms.
Perform manual recoding of un-coded product and substance terms arising from ICSRs.
Support SPOR / IDMP-related activities.
Maintain safety tracking for assigned activities.
Ensure all relevant documents are submitted to the Trial Master File (TMF) for clinical trials and the Pharmacovigilance System Master File (PSMF) for post-marketing programs, as applicable.
Apply safety reporting regulatory intelligence to all safety reporting activities.
Perform literature screening and safety review.
Maintain drug dictionaries and support coding activities.
Maintain compliance with SOPs, Work Instructions (WIs), GCP, ICH guidelines, GVP, and global drug/biologic/device regulations.
Participate in audits and support inspection readiness.
Foster constructive and professional working relationships with internal and external stakeholders.
Education: B.Pharm / M.Pharm / PharmD / BDS / BMS / MBBS
(B.Sc / M.Sc not eligible)
Minimum 1 year of experience handling Product Quality Complaint (PQC) cases exclusively.
Experience in handling medical research-related safety cases.
Hands-on experience in Argus / ARISg safety database.
Strong understanding of global pharmacovigilance regulations and reporting requirements.
Knowledge of clinical trial phases II–IV and/or post-marketing safety.
Proficiency in Microsoft Office applications
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.
