Job Title: Safety & Pharmacovigilance (PV) Specialist I – QC Experience
Location: Hyderabad, India
Job Type: Full-Time, Regular
Job ID: 25104167
Category: Pharmacovigilance | Drug Safety | Clinical Development
Company Overview:
Syneos Health® is a leading global biopharmaceutical solutions organization, delivering integrated clinical, medical affairs, and commercial expertise to accelerate the development of life-changing therapies. With a workforce of 29,000 employees across 110 countries, we focus on simplifying clinical development while maintaining high standards of quality and patient safety.
Role Overview:
We are seeking a Safety & PV Specialist I with Quality Control (QC) experience to join our Hyderabad Pharmacovigilance team. The ideal candidate will have a strong background in ICSR processing, QC review, and regulatory compliance, supporting clinical trials (Phases II–IV) and post-marketing safety activities. This role is critical in ensuring accurate, timely, and compliant safety reporting in alignment with global regulatory requirements.
Key Responsibilities:
Case Processing & Quality Control:
Enter, triage, and track Individual Case Safety Reports (ICSRs) in PVG quality and tracking systems.
Perform data review for completeness, accuracy, and regulatory reportability.
Code adverse events, medical history, concomitant medications, and lab tests using MedDRA.
Prepare comprehensive narrative summaries and resolve queries effectively.
Identify and manage duplicate ICSRs and recode unprocessed product and substance terms as required.
Regulatory & Safety Reporting:
Assist in the timely preparation and submission of expedited safety reports per global regulatory requirements.
Maintain tracking of all assigned safety activities.
Support xEVMPD product record validation and submission and SPOR/IDMP-related activities.
Ensure compliance with SOPs, Work Instructions, GCP, ICH guidelines, and GVP standards.
Data & Literature Management:
Perform literature screening and safety signal assessment.
Maintain drug dictionaries and coding accuracy in safety databases.
Participate in audits and support regulatory inspections as required.
Collaboration & Process Improvement:
Foster professional working relationships across internal teams and external stakeholders.
Contribute to process improvement initiatives in pharmacovigilance and case management.
Support cross-functional teams in delivering high-quality safety data for clinical development.
Required Qualifications & Experience:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent.
Minimum 3 years of experience in ICSR processing with QC exposure.
Experience handling clinical trial (Phases II–IV), post-marketing surveillance, and spontaneous cases.
Strong knowledge of safety database systems, MedDRA coding, and medical terminology.
Understanding of global pharmacovigilance regulations, ICH GCP, and GVP standards.
Proficiency in Microsoft Office Suite, email, shared content platforms, and internet research.
Strong organizational skills with the ability to manage multiple tasks and meet deadlines.
Excellent written and verbal communication skills.
Preferred Skills:
Experience supporting regulatory submissions, audits, and pharmacovigilance quality review processes.
Familiarity with post-marketing safety activities and compliance with international safety reporting standards.
Why Join Syneos Health:
Be part of a global team working on novel FDA-approved and EMA-authorized products.
Opportunity for career growth, technical training, and professional development.
Work in a diverse and inclusive environment that values innovation and collaboration.
Make a meaningful impact on patient safety and the drug development process.
Compensation & Benefits:
Competitive salary with benefits including health coverage, paid leave, training programs, and career development opportunities.
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