Safety & PV Specialist I
Location: India – Gurugram / Hyderabad (Hybrid)
Job ID: 25103004
Updated: Yesterday
Organization: Syneos Health
✅ About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization focused on accelerating clinical development, medical affairs, and commercial outcomes. With 29,000 employees across 110 countries, the company emphasizes:
A patient-centric clinical model
Simplified and streamlined processes
A collaborative, innovative work culture
Strong focus on employee development, inclusion, and “Total Self Culture”
Work Here Matters Everywhere.
✅ Position Overview: Safety & PV Specialist I
Experience Required: 2.5 – 4 years
Education:
Allowed: B. Pharm, M. Pharm, BDS, BMS, MBBS
Not allowed: BSc / MSc
Tools:
Argus Safety Database
Aris-G
The role is responsible for end-to-end ICSR case processing, literature review, coding, safety data quality, regulatory compliance, and tracking within global PV systems.
✅ Key Responsibilities
📌 ICSR Case Processing
Perform data entry, booking & triage of ICSRs
Process ICSRs per SOPs and project-specific safety plans
Evaluate ICSR data for completeness, accuracy, and reportability
Enter data into the safety database
Code:
Adverse events
Medical history
Concomitant medications
Lab tests & procedures
Prepare narrative summaries
Identify missing information, raise queries, and track them to resolution
Ensure timely and accurate expedited reporting as per global regulations
📌 Quality & Compliance
Maintain safety tracking for assigned activities
Perform quality review of ICSRs
Manage duplicate case identification
Maintain compliance with:
SOPs & Work Instructions
GCP, ICH, GVP guidelines
Global regulatory requirements
Programs and study protocols
📌 Coding & Regulatory Activities
MedDRA coding
Substance and product term recoding (manual)
Literature screening & review
xEVMPD record validation & submission
SPOR / IDMP-related activities
Maintain drug dictionary and coding consistency
📌 Documentation
Ensure all relevant documents are filed in:
Trial Master File (TMF) for clinical trials
PV System Master File for post-marketing
Maintain data accuracy within PV quality/tracking systems
📌 Collaboration & Audits
Foster professional working relationships with internal & external teams
Participate in audits as required
Apply regulatory intelligence maintained by Syneos Health
✅ Required Qualifications
2.5 – 4 years of PV experience
Education as listed above (BPharm preferred)
Proficiency in Argus or Aris-G
Strong knowledge of GVP, ICH, drug development
Excellent attention to detail, communication & organizational skills
Ability to work independently and collaboratively
✅ Why Join Syneos Health?
Strong focus on career development & progression
Supportive leadership & inclusive culture
Technical & therapeutic area training
Global exposure, collaborative work environment
Recognition programs & total rewards
✅ About Syneos Health’s Impact
Worked with 94% of all FDA-approved novel drugs in the past 5 years
Supported 95% of EMA-authorized products
Contributed to 200+ studies across 73,000 sites and 675,000+ patients
✅ Additional Information
Responsibilities listed are not exhaustive
Equivalent experience/education may be considered
Committed to diversity, inclusion, and compliance with disability accommodations
Gujarat :
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Croatia |Zagreb :
Zagreb |Estonia :
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