Safety & PV Specialist I - Medical Device & Product Quality

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: Hyderabad / 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, quality review, regulatory reporting support, and compliance activities. The role requires demonstrated expertise in Product Quality Complaint case handling and medical research safety cases.

Key Responsibilities

Perform end-to-end ICSR processing and quality review.

Conduct medical coding (events, medical history, concomitant medications, laboratory data).

Prepare comprehensive narratives and manage follow-up queries.

Identify and manage duplicate ICSRs.

Support xEVMPD validation and submission activities.

Contribute to SPOR / IDMP-related activities.

Maintain safety tracking and ensure timely regulatory submissions.

Support audit readiness and regulatory inspections.

Ensure adherence to SOPs, GVP, ICH-GCP, and global safety regulations.

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 safety cases.

Hands-on experience in Argus / ARISg safety database.

Strong understanding of global pharmacovigilance regulations.

Experience in clinical trial and/or post-marketing safety reporting.

Skills & Competencies

Strong organizational and prioritization skills





High level of accuracy and compliance focus

Effective stakeholder coordination skills

Ability to work in a deadline-driven environment

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 workplace. 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.

📌 Safety & PV Specialist I - Medical Device & Product Quality (Gurugram)
🏢 Leading
📍 Gurugram