Safety & PV Specialist I
Location: India-Asia Pacific - IND-Gurugram-DLF Downtown
Job ID: 25003309
About Syneos Health:
Syneos Health® is a fully integrated biopharmaceutical solutions organization built to accelerate customer success. With 29,000 employees across 110 countries, we bring the customer and the patient to the center of everything we do. Whether in a Functional Service Provider or Full-Service environment, we strive to streamline clinical, medical affairs, and commercial operations, creating better, faster ways to get therapies to patients.
Why Work With Us:
Supportive and engaged line management.
Career development and progression.
Inclusive Total Self culture.
A collaborative environment to help customers achieve their goals.
Work that truly matters—impacting lives globally.
Job Responsibilities:
Data Handling & Entry:
Enter and track information for Individual Case Safety Reports (ICSRs).
Assist in processing ICSRs per SOPs and project-specific plans.
Evaluate ICSR data for completeness and accuracy.
Database Management:
Code events, medical history, concomitant medications, and lab tests.
Perform MedDRA coding and maintain the drug dictionary.
Validate and submit xEVMPD product records.
Narrative & Documentation:
Compile narrative summaries.
Query missing information and resolve queries.
Ensure documentation compliance with TMF and PSMF requirements.
Quality & Compliance:
Maintain safety tracking and perform literature screening.
Conduct quality reviews of ICSRs.
Identify and manage duplicate ICSRs.
Participate in audits as required.
Apply safety reporting intelligence to all activities.
Cross-functional Collaboration:
Work constructively with internal and external team members.
Engage in tasks related to SPOR / IDMP activities.
Qualifications:
Education & Experience:
Bachelor’s degree in life sciences, pharmacy, or nursing—or equivalent.
Knowledge of medical terminology and safety databases.
Regulatory Understanding:
Familiarity with ICH GCP, GVP, clinical trial phases, and post-marketing safety requirements.
Technical Skills:
Proficiency in Microsoft Office, Outlook, and team collaboration tools.
Personal Skills:
Strong organizational and multitasking abilities.
Excellent verbal and written communication.
Attention to detail and ability to meet deadlines.
Ability to work independently and within a team.
Note:
Tasks and responsibilities may evolve based on project or organizational needs. Equivalent education and experience will be considered. The company remains compliant with applicable disability laws and provides reasonable accommodations when required.
Work Here Matters Everywhere.
Be part of an organization that challenges the status quo and embraces diversity, inclusion, and innovation in every role.
Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
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Siliguri |Illinois :
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Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Japan | Saitama |Tokyo :
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