Job Title: Safety & Pharmacovigilance Specialist I (Literature Case Review)
Location: Gurugram, Haryana, India
Company: Syneos Health
Job Type: Full-Time | Experience: 0–2 years
About the Company:
Syneos Health® is a leading integrated biopharmaceutical solutions organization that partners with global pharma and biotech innovators. With 29,000 employees across 110 countries, Syneos has supported 94% of all novel FDA-approved drugs in the past five years. The company blends clinical development expertise with medical affairs and commercial insights to accelerate the delivery of therapies that improve patient outcomes.
Role Overview:
As a Safety & PV Specialist I, you will play a key role in pharmacovigilance operations by conducting systematic literature reviews for safety cases (ICSRs), ensuring regulatory compliance, and supporting global safety surveillance. This entry-to-mid level role is ideal for graduates in life sciences or pharmacy with strong analytical and documentation skills.
Key Responsibilities:
Conduct systematic and ad-hoc literature searches in databases (Embase, PubMed, Medline) for ICSR identification.
Extract and summarize safety-relevant information from literature sources.
Develop and validate literature search strategies for pharmacovigilance purposes.
Enter ICSR data into safety databases; ensure accuracy, completeness, and regulatory compliance.
Perform MedDRA coding (events, medical history, drugs, tests).
Compile narrative summaries and resolve safety data queries.
Support reporting of expedited and periodic safety reports as per regulatory timelines.
Conduct literature screening for drug coding and maintenance of product dictionaries.
Perform xEVMPD record validation and submissions; manage SPOR/IDMP-related activities.
Identify and reconcile duplicate ICSRs; ensure quality review of cases.
Ensure compliance with SOPs, GVP, ICH-GCP, global regulations, and client safety plans.
Contribute to audits, inspections, and Trial Master File submissions.
Qualifications:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent.
0–2 years of experience in pharmacovigilance, literature review, or drug safety preferred.
Strong knowledge of medical terminology, ICSR processes, and global PV regulations (ICH, GVP, FDA, EMA).
Hands-on familiarity with safety databases (e.g., Argus, ArisG, or equivalent).
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Strong organizational and time management skills; ability to manage multiple priorities.
Excellent written and verbal communication skills.
Skills & Competencies:
High attention to detail with accuracy in safety case processing.
Ability to work independently and collaboratively in a team setting.
Strong problem-solving and critical thinking mindset.
Flexible to meet deadlines in a dynamic regulatory environment.
Compensation & Benefits:
Competitive entry-level package (₹4–7 LPA market benchmark for PV roles).
Global exposure to advanced PV practices and regulatory requirements.
Career progression in Safety & Pharmacovigilance pathways.
Professional training in literature review and safety database operations.
Inclusive culture that promotes diversity and career development.
Why Join Syneos Health?
Work with one of the world’s leading CROs trusted by top pharma companies.
Exposure to cutting-edge safety surveillance tools and literature review strategies.
Growth opportunities in global pharmacovigilance, regulatory writing, and medical review.
Be part of a culture that values Total Self – authenticity, diversity, and continuous learning.
Gujarat :
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