Vacancy as Safety & PV Specialist-II (Literature Case Processing) for BPharm/ MPharm/ PharmD/ BDS Graduates at Syneos pharma ltd, Gurgaon

GPAT India; Gurugram District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

GPAT India is seeking a Safety & PV Specialist II – Literature Case Processing to join our pharmacovigilance team in India. You will perform literature screening, MLM activities, and ICSR processing, ensuring data accuracy and regulatory compliance across global programs.

The role requires 4-7 years of PV experience, strong MedDRA coding, and proficiency with safety databases, MS Office, and collaborative tools. Remote work not offered; on-site in Gurgaon region.

Qualifications

• 4-7 years of Pharmacovigilance experience, including literature case processing and MLM.
• Strong hands-on experience in ICSR processing, literature surveillance, data entry, narrative writing, and case management.
• Working knowledge of safety databases, MedDRA coding, and medical terminology.
• Familiarity with ICH-GCP, GVP, and pharmacovigilance regulations.

Responsibilities

• Enter information into PV quality and tracking systems for receipt and tracking of IC SRS, process literature-derived SRS per SOPs and safety plans.
• Perform comprehensive literature screening, review, and MLM activities to identify and process potential adverse events.
• Maintain safety tracking systems and ensure timely completion of activities and deliverables.
• Conduct MedDRA coding, drug coding, and maintenance of drug dictionaries as required.
• Perform quality review of IC SRS for regulatory compliance.
• Identify, reconcile, and manage duplicate safety cases.
• Support validation and submission activities related to xEVMPD, SPOR, and IDMP requirements.
• Assist with manual recoding of products, substances, and indication terms as needed.
• Ensure safety documentation is filed per company and client requirements.
• Maintain SOP/GVP/ICH-GCP compliance and participate in audits and quality improvements.
• Apply regulatory intelligence and PV knowledge to safety processing and reporting.
• Foster effective relationships with internal and external stakeholders.

Skills

ICSR processing

Literature surveillance

Medical Literature Monitoring

Data entry

Narrative writing

MedDRA coding

Safety databases

ICH-GCP

GVP

Education

M.Pharm, PharmD, B.Pharm, BDS or equivalent

Tools

Microsoft Office

Outlook

Job description

Post Name:Safety & PV Specialist II – Literature Case Processing

Job Responsibilities

• Enter information into PV quality and tracking systems for receipt and tracking of IC SRS. Process literature-derived IC SRS according to SOPs and project-specific safety plans. Evaluate case data for completeness, accuracy, and regulatory reportability. Conduct data entry, coding, narrative writing, and follow-up activities as required.
• Perform comprehensive literature screening, review, and Medical Literature Monitoring (MLM) activities to identify and process potential adverse events.
• Maintain safety tracking systems and ensure timely completion of assigned activities and deliverables.
• Conduct MedDRA coding, drug coding, and maintenance of drug dictionaries as required.
• Perform quality review of IC SRS and ensure compliance with project and regulatory requirements.
• Identify, reconcile, and manage duplicate safety cases.
• Support validation and submission activities related to xEVMPD, SPOR, and IDMP requirements.
• Assist with manual recoding of products, substances, and indication terms when required.
• Ensure all relevant safety documentation is maintained and filed appropriately in accordance with company and client requirements.
• Maintain compliance with SOPs, Work Instructions, GVP, ICH-GCP guidelines, global safety regulations, and project-specific procedures.
• Participate in audits, inspections, and quality improvement initiatives as required.
• Apply regulatory intelligence and pharmacovigilance knowledge to safety processing and reporting activities.
• Foster effective working relationships with internal and external stakeholders and contribute to a collaborative team environment.

Qualifications

• 4-7 years of Pharmacovigilance experience, including significant experience in Literature Case Processing and Medical Literature Monitoring (MLM).
• M.Pharm, PharmD, B.Pharm, BDS, or equivalent healthcare-related qualification.
• Strong hands‑on experience in ICSR processing, literature surveillance, data entry, narrative writing, and case management.
• Working knowledge of safety databases, MedDRA coding, and medical terminology.
• Good understanding of clinical trials, post‑marketing safety requirements, ICH‑GCP, GVP, and pharmacovigilance regulations.
• Experience in quality review activities and regulatory compliance processes.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and other collaborative platforms.
• Ability to work independently and effectively within global teams.
• Excellent written and verbal communication skills.
• Strong organizational, analytical, and prioritization skills with the ability to manage multiple activities simultaneously.
• Detail‑oriented with a high degree of accuracy and commitment to quality and compliance.