06 Aug
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Budaun
06 Aug
The Pharma Daily - Powered by Vigisolvo
Budaun
Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding
Safety & PV Specialist I - PQC Company: Syneos Health
Location: Gurgaon, India
Job ID: 25107950
Employment Type: Full-Time
Work Mode: Office-Based
Experience Required: 2.5 – 4 Years
About Syneos Health Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The company partners with innovators across the drug development and commercialization continuum, helping navigate complexity and accelerate progress.
Syneos Health Focuses On:
- Clinical development solutions
- Medical affairs
- Commercial insights
- Patient-focused healthcare innovation
Job Summary The Safety & Pharmacovigilance Specialist I – Medical Device & PQC is responsible for:
- End-to-end Individual Case Safety Report (ICSR) processing
- Safety data management
- Regulatory reporting support
- Compliance with global pharmacovigilance regulations
- Product Quality Complaint (PQC) case handling
- Medical research-related safety case processing
Key Responsibilities ICSR Processing & Case Management
- Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
- Process ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.
- Triage ICSRs and evaluate
- Completeness
- Accuracy
- Regulatory reportability
- Enter case data into safety databases such as:
- Argus
- ARISg
- Perform coding of
- Adverse events
- Medical history
- Concomitant medications
- Laboratory tests
- Code using
- MedDRA
- Relevant medical dictionaries
- Prepare accurate medical narrative summaries.
- Identify missing or inconsistent information.
- Follow up on queries until resolution.
- Identify and manage duplicate ICSRs.
- Perform quality review of ICSRs.
Regulatory Reporting & Compliance
- Support preparation and submission of expedited safety reports.
- Ensure reporting activities comply with global regulatory requirements.
- Validate and submit xEVMPD product records.
- Perform MedDRA coding of indication terms.
- Perform manual recoding of uncoded product and substance terms.
- Support SPOR / IDMP activities.
- Maintain safety tracking activities.
- Ensure documentation submission to
- Trial Master File (TMF)
- Pharmacovigilance System Master File (PSMF)
- Apply safety reporting regulatory intelligence.
- Maintain compliance with
- SOPs
- Work Instructions (WIs)
- GCP
- ICH guidelines
- GVP regulations
- Global drug, biologic, and device regulations
Literature, Audit & Collaboration
- Perform literature screening and safety reviews.
- Maintain drug dictionaries.
- Support coding activities.
- Participate in audits and inspection readiness activities.
- Maintain professional relationships with:
- Internal teams
- External stakeholders
- Project partners
Required Qualifications Education Eligible Qualifications:
- B.Pharm
- M.Pharm
- PharmD
- BDS
- BMS
- MBBS
Not Eligible:
- B.Sc
- M.Sc
Required Experience & Skills
- Minimum 1 year of experience handling Product Quality Complaint (PQC) cases exclusively.
- Experience handling medical research-related safety cases.
- Hands-on experience with:
- Argus safety database
- ARISg safety database
- Robust understanding of
- Pharmacovigilance regulations
- Safety reporting requirements
- Knowledge of
- Clinical trial phases II–IV
- Post-marketing safety
- Proficiency in Microsoft Office applications.
About Syneos Health Syneos Health has supported:
- 94% of Novel FDA Approved Drugs
- 95% of EMA Authorized Products
- 200+ studies across 73,000 sites
- 675,000+ clinical trial patients
The Organization Promotes:
- Career development
- Technical training
- Inclusive workplace culture
- Global collaboration
Equal Opportunity Statement Syneos Health is committed to building a diverse and inclusive workplace. The company provides equal employment opportunities and reasonable accommodations for qualified individuals with disabilities. Safety & PV Specialist I - PQC Company: Syneos Health
Location: Gurgaon, India
Job ID: 25107950
Employment Type: Full-Time
Work Mode: Office-Based
Experience Required: 2.5 – 4 Years
Syneos Health Focuses On:
- Clinical development solutions
- Medical affairs
- Commercial insights
- Patient-focused healthcare innovation
Job Summary The Safety & Pharmacovigilance Specialist I – Medical Device & PQC is responsible for:
- End-to-end Individual Case Safety Report (ICSR) processing
- Safety data management
- Regulatory reporting support
- Compliance with global pharmacovigilance regulations
- Product Quality Complaint (PQC) case handling
- Medical research-related safety case processing
Key Responsibilities ICSR Processing & Case Management
- Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs.
- Process ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.
- Triage ICSRs and evaluate
- Completeness
- Accuracy
- Regulatory reportability
- Enter case data into safety databases such as:
- Argus
- ARISg
- Perform coding of
- Adverse events
- Medical history
- Concomitant medications
- Laboratory tests
- Code using
- MedDRA
- Relevant medical dictionaries
- Prepare accurate medical narrative summaries.
- Identify missing or inconsistent information.
- Follow up on queries until resolution.
- Identify and manage duplicate ICSRs.
- Perform quality review of ICSRs.
Regulatory Reporting & Compliance
- Support preparation and submission of expedited safety reports.
- Ensure reporting activities comply with global regulatory requirements.
- Validate and submit xEVMPD product records.
- Perform MedDRA coding of indication terms.
- Perform manual recoding of uncoded product and substance terms.
- Support SPOR / IDMP activities.
- Maintain safety tracking activities.
- Ensure documentation submission to
- Trial Master File (TMF)
- Pharmacovigilance System Master File (PSMF)
- Apply safety reporting regulatory intelligence.
- Maintain compliance with
- SOPs
- Work Instructions (WIs)
- GCP
- ICH guidelines
- GVP regulations
- Global drug, biologic, and device regulations
Literature, Audit & Collaboration
- Perform literature screening and safety reviews.
- Maintain drug dictionaries.
- Support coding activities.
- Participate in audits and inspection readiness activities.
- Maintain professional relationships with:
- Internal teams
- External stakeholders
- Project partners
Eligible Qualifications:
- B.Pharm
- M.Pharm
- PharmD
- BDS
- BMS
- MBBS
Not Eligible:
- B.Sc
- M.Sc
Required Experience & Skills
- Minimum 1 year of experience handling Product Quality Complaint (PQC) cases exclusively.
- Experience handling medical research-related safety cases.
- Hands-on experience with:
- Argus safety database
- ARISg safety database
- Strong understanding of
- Pharmacovigilance regulations
- Safety reporting requirements
- Knowledge of
- Clinical trial phases II–IV
- Post-marketing safety
- Proficiency in Microsoft Office applications.
Syneos Health Has Supported:
- 94% of Novel FDA Approved Drugs
- 95% of EMA Authorized Products
- 200+ studies across 73,000 sites
- 675,000+ clinical trial patients
The Organization Promotes:
- Career development
- Technical training
- Inclusive workplace culture
- Global collaboration
Equal Opportunity Statement Syneos Health is committed to building a diverse and inclusive workplace. The company provides equal employment opportunities and reasonable accommodations for qualified individuals with disabilities.
📌 Safety & PV Specialist I - PQC (Budaun)
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