Syneos HealthSafety & PV Specialist I - Medical Device & PQC
Safety & PV Specialist I - Medical Device & PQC
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 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
Job Title: Safety & Pharmacovigilance Specialist I
Location: Gurugram, India (Office-Based)
Employment Type: Full-Time
Experience Required: 2.5 – 4 Years
Job Summary
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.
Key Responsibilities
ICSR Processing & Case Management
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.
Regulatory Reporting & Compliance
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.
Literature, Audit & Collaboration
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.
Required Qualifications
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.
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.