Syneos Health®, a global biopharmaceutical solutions organization, is hiring a Safety & Pharmacovigilance (PV) Coordinator for its Hyderabad office. This opportunity is ideal for B.Pharm or M.Pharm graduates with at least 1 year of experience in post-marketing safety (PMS) and spontaneous case processing.

If you are looking to build a strong career in Pharmacovigilance, Drug Safety Operations, and ICSR Processing, this role offers exposure to global safety databases, regulatory reporting, and compliance with ICH-GCP and GVP standards.

🔍 Key Job Details

• Position: Safety & PV Coordinator
• Company: Syneos Health
• Location: Hyderabad
• Employment Type: Full-time, Office-based
• Experience Required: Minimum 1 year
• Education: B.Pharm / M.Pharm only

🧾 Job Responsibilities

• Enter and track Individual Case Safety Reports (ICSRs) in PVG systems.
• Process ICSRs according to SOPs and project-specific safety plans.
• Triage cases and assess data for completeness, accuracy, and regulatory reportability.
• Code adverse events, medical history, concomitant medications, and tests using MedDRA.
• Prepare high-quality case narratives.
• Perform duplicate case detection and management.
• Conduct literature screening and safety review.
• Support xEVMPD product record validation and submission.
• Perform manual recoding of product and substance terms.
• Participate in SPOR/IDMP activities.
• Ensure documentation is filed in TMF and PV System Master File.
• Maintain compliance with ICH-GCP, GVP, and global PV regulations.
• Support audits and inspections.

2. Sr. CRA I / CRA II

Company: Syneos Health
Position: Sr. CRA I / CRA II
Location: Mumbai, India
Employment Type: Full-time, Office-based
Experience: Minimum 4 years of on-site monitoring experience as a CRA
Job Requisition ID: 25113134

Eligibility / Qualifications

Candidates should have:

• Minimum 4 years of on-site monitoring experience as a CRA.
• Experience in core clinical trials.
• Experience working as an on-site CRA.
• FSP experience is preferred.
• Preferred therapeutic areas include Oncology, Cardiology and Vaccines.
• Bachelor’s degree or RN in a related field, or an equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements.
• Good computer skills and ability to adopt new technologies.
• Excellent communication, presentation and interpersonal skills.
• Basic critical-thinking skills.
• Ability to manage travel of up to 75% on a regular basis.

Job Responsibilities

The Sr. CRA I / CRA II will:

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits.
• Ensure regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Evaluate site and site staff performance and provide recommendations regarding site-specific actions.
• Communicate and escalate serious issues to the project team and develop action plans.
• Verify informed consent processes and documentation.
• Protect subject/patient confidentiality.
• Assess factors affecting patient safety and clinical data integrity, including protocol deviations/violations and pharmacovigilance issues.
• Conduct Source Document Review and review medical records.
• Verify clinical data entered in CRFs against source documents.
• Support query resolution and ensure queries are resolved within agreed timelines.
• Verify compliance with electronic data capture requirements.
• Perform investigational product inventory and reconciliation activities when required.
• Review IP storage, security, dispensing and administration according to protocol.
• Review Investigator Site Files for accuracy, timeliness and completeness.
• Reconcile ISF contents with the Trial Master File.
• Document monitoring activities through required project documentation.
• Support subject recruitment, retention and awareness strategies.
• Track observations, ongoing status and action items.
• Manage site-level activities and communication to meet project objectives, deliverables and timelines.
• Act as a liaison with project site personnel when required.
• Ensure assigned sites and project-specific site team members are trained and compliant.
• Attend Investigator Meetings, sponsor meetings and clinical training sessions.
• Support audit readiness and audit follow-up activities.
• Provide training or mentorship to junior CRAs when assigned.

For Real World Late Phase activities, responsibilities may also include site support throughout the study lifecycle, chart abstraction and data collection, collaboration with sponsors and affiliates, identifying potential sites, developing country-level informed consent forms, collaborating with regulatory teams, participating in bid defense meetings and identifying operational efficiencies.

Required Skills

• Clinical trial monitoring
• Core clinical trials
• On-site monitoring
• Good Clinical Practice (GCP)
• ICH Guidelines
• Pharmacovigilance
• Source Document Review
• Clinical data review
• Query resolution
• Investigator Site File (ISF)
• Trial Master File (TMF)
• Investigational Product management
• Regulatory compliance
• Communication and interpersonal skills
• Presentation skills
• Computer skills
• Critical thinking

Application