Syneos Health Hiring Safety & PV Specialist I – Medical Device & PQC
- Syneos Health Hiring Safety & PV Specialist I – Medical Device & PQC | BPharm, PharmD | Gurugram
- Company Overview
- Job Role & Responsibilities
- ICSR Processing & Case Management
- Regulatory Reporting & Compliance
- Literature Review, Audit & Collaboration
- Eligibility & Qualifications
- Educational Background
- Experience Requirements
- Location & Employment Details
- Application Process
- Frequently Asked Questions (FAQs)
- 1. Is PQC experience mandatory?
- 2. Are B.Sc or M.Sc candidates eligible?
- 3. Is experience in Argus required?
- 4. Is this a remote role?
- 5. What regulatory knowledge is important?
- Summary Table
Syneos Health Hiring Safety & PV Specialist I – Medical Device & PQC | BPharm, PharmD | Gurugram
Syneos Health is hiring a Safety & Pharmacovigilance Specialist I – Medical Device & PQC for its Pharmacovigilance and Drug Safety department in Gurugram, India. This is a full-time, office-based opportunity for experienced safety professionals with 2.5–4 years of pharmacovigilance experience, including mandatory exposure to Product Quality Complaint (PQC) case handling. Candidates with B.Pharm, M.Pharm, PharmD, BDS, BMS, or MBBS qualifications are eligible to apply.
This role focuses on end-to-end ICSR processing, safety data management, regulatory reporting, and global pharmacovigilance compliance. It is ideal for professionals aiming to strengthen their expertise in Argus/ARISg safety databases, MedDRA coding, regulatory submissions, and medical device vigilance within a global biopharmaceutical solutions organization.
Company Overview
entity[“organization”,”Syneos Health”,”biopharmaceutical solutions company”] is a fully integrated biopharmaceutical solutions organization operating across clinical development, medical affairs, and commercialization services. With approximately 29,000 employees across 110 countries, Syneos Health supports pharmaceutical, biotechnology, and medical device companies in accelerating therapy development and regulatory success.
Over the past five years, Syneos Health has contributed to the development of 94% of novel FDA-approved drugs and 95% of EMA-authorized products. The organization works across thousands of clinical trial sites globally and plays a critical role in delivering safe and effective therapies to patients.
Its Clinical Development model places both the patient and customer at the center of operations, focusing on regulatory excellence, compliance, and innovation in safety reporting and pharmacovigilance processes.
Job Role & Responsibilities
The Safety & PV Specialist I will manage individual case safety reports (ICSRs), ensure compliance with global pharmacovigilance regulations, and support regulatory reporting for medical devices and post-marketing programs.
ICSR Processing & Case Management
- Perform end-to-end processing of ICSRs in accordance with SOPs and project-specific safety plans.
- Enter and track cases in pharmacovigilance quality and safety tracking systems.
- Triage ICSRs for completeness, regulatory reportability, and data accuracy.
- Enter case data into safety databases such as Argus or ARISg.
- Code adverse events, medical history, concomitant medications, and laboratory data using MedDRA and relevant dictionaries.
- Prepare medically accurate and comprehensive case narratives.
- Identify missing information and follow up on case queries until resolution.
- Detect and manage duplicate ICSRs.
- Conduct quality review of processed cases.
Regulatory Reporting & Compliance
- Assist in preparation and submission of expedited safety reports in compliance with global pharmacovigilance regulations.
- Validate and submit xEVMPD product records with appropriate MedDRA coding.
- Perform manual recoding of uncoded product and substance terms.
- Support SPOR and IDMP-related activities.
- Maintain safety tracking logs for assigned responsibilities.
- Ensure documentation is filed in Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) as required.
- Apply regulatory intelligence in safety reporting activities.
Literature Review, Audit & Collaboration
- Perform literature screening and safety review activities.
- Maintain drug dictionaries and coding tools.
- Ensure compliance with GCP, ICH guidelines, GVP, and global device and biologic regulations.
- Participate in internal and external audits and support inspection readiness.
- Maintain strong collaboration with cross-functional teams and external stakeholders.
This role requires precision, regulatory awareness, and structured documentation skills in a compliance-driven environment.
Eligibility & Qualifications
Educational Background
Eligible qualifications include:
B.Pharm, M.Pharm, PharmD, BDS, BMS, MBBS.
Note: B.Sc and M.Sc candidates are not eligible.
Experience Requirements
- 2.5–4 years of pharmacovigilance experience.
- Minimum 1 year of exclusive experience handling Product Quality Complaint (PQC) cases.
- Experience in medical research-related safety case processing.
- Hands-on experience in Argus or ARISg safety databases.
- Strong knowledge of global pharmacovigilance regulations and reporting standards.
- Understanding of clinical trial phases II–IV and post-marketing safety surveillance.
- Proficiency in Microsoft Office tools.
Candidates must demonstrate strong analytical skills, regulatory compliance awareness, and the ability to manage multiple safety cases within strict timelines.
Location & Employment Details
- Location: Gurugram, India
- Work Model: Office-Based
- Employment Type: Full-Time
- Experience Required: 2.5–4 Years
- Job Requisition ID: 25105574
Application Process
Interested candidates can apply directly through the official Syneos Health careers portal using the link below:
Applicants should highlight their PQC handling experience, Argus/ARISg database exposure, and regulatory submission expertise in their resume.
Frequently Asked Questions (FAQs)
1. Is PQC experience mandatory?
Yes, at least 1 year of exclusive Product Quality Complaint case handling experience is required.
2. Are B.Sc or M.Sc candidates eligible?
No, only specified medical and pharmacy qualifications are eligible.
3. Is experience in Argus required?
Yes, hands-on experience in Argus or ARISg safety databases is required.
4. Is this a remote role?
No, this is an office-based position in Gurugram.
5. What regulatory knowledge is important?
Knowledge of GCP, ICH, GVP, global pharmacovigilance regulations, and device reporting requirements is essential.
Summary Table
| Company | Syneos Health |
| Vacancies | Safety & Pharmacovigilance Specialist I – Medical Device & PQC |
| Required Education | B.Pharm, M.Pharm, PharmD, BDS, BMS, MBBS |
| Experience | 2.5–4 years PV experience; minimum 1 year PQC handling |
To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.
