Safety & Pharmacovigilance Specialist II
(Literature or Clinical Trial Case Processing)
Location: Hyderabad / Gurugram, India
Job ID: 25104809
Employment Type: Full-Time
Function: Pharmacovigilance | Drug Safety | Clinical Research
Experience Required: Minimum 3.5 Years
Last Updated: January 20, 2026
About the Company
Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating the development and delivery of life-changing therapies. Operating across more than 110 countries, Syneos Health integrates clinical development, pharmacovigilance, and medical affairs expertise to support pharmaceutical, biotechnology, and medical device companies worldwide.
With a strong patient-centric and customer-focused Clinical Development model, Syneos Health continuously innovates to simplify processes, enhance quality, and deliver regulatory-compliant solutions across the drug development lifecycle.
Job Overview
The Safety & Pharmacovigilance Specialist II will be responsible for end-to-end processing of Individual Case Safety Reports (ICSRs) arising from clinical trials and/or scientific literature. The role requires strong pharmacovigilance expertise, hands-on experience with safety databases, and in-depth knowledge of global safety regulations.
This position plays a critical role in ensuring accurate safety data management, regulatory compliance, and high-quality reporting in line with international pharmacovigilance standards.
Key Responsibilities
Perform receipt, tracking, and processing of ICSRS in pharmacovigilance quality and tracking systems
Triage safety cases and evaluate data for completeness, accuracy, and regulatory reportability
Enter and maintain safety data in validated safety databases
Code adverse events, medical history, concomitant medications, and laboratory data using MedDRA and drug dictionaries
Prepare clear, accurate, and comprehensive case narratives
Identify missing or unclear information, generate queries, and follow up to resolution
Support timely preparation and submission of expedited safety reports in compliance with global regulatory timelines
Maintain safety tracking logs for assigned activities
Conduct literature screening and review for safety reporting
Perform xEVMPD product record validation and submission, including MedDRA indication coding
Conduct manual recoding of un-coded product and substance terms from ICSRs
Identify and manage duplicate safety cases
Support activities related to SPOR / IDMP
Perform quality review of ICSRs and related safety documentation
Ensure submission of required documents to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Maintain compliance with SOPs, Work Instructions, ICH-GCP, GVP, and global safety regulations
Participate in internal and external audits and inspections as required
Apply pharmacovigilance regulatory intelligence to daily safety reporting activities
Foster effective collaboration with internal teams, sponsors, and external stakeholders
Required Qualifications
Education:
Bachelor’s or Master’s degree in Pharmacy or Life Sciences
Accepted qualifications: B.Pharm, M.Pharm, PharmD, BDS
Experience:
Minimum 3.5 years of hands-on experience in pharmacovigilance
Mandatory experience in clinical trial case processing or literature case processing
Proven experience in ICSR processing and safety data management
Skills & Competencies
Strong knowledge of pharmacovigilance processes and global safety regulations
Good understanding of clinical trial phases II–IV and/or post-marketing safety requirements
Proficiency in MedDRA coding, medical terminology, and drug dictionaries
Experience working with safety database systems (e.g., ARGUS or equivalent)
Familiarity with ICH-GCP, GVP, and international regulatory requirements
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and shared document management systems
Excellent written and verbal communication skills
Strong organizational skills with the ability to manage multiple priorities
Detail-oriented with a high level of accuracy and ability to meet regulatory deadlines
Ability to work independently as well as collaboratively within cross-functional teams
Why Join Syneos Health?
Work with a global organization involved in the majority of newly approved FDA and EMA products
Exposure to diverse pharmacovigilance programs across clinical and post-marketing domains
Strong focus on employee development, training, and career progression
Inclusive workplace culture that values diversity, collaboration, and professional growth
Equal Opportunity Statement
Syneos Health is committed to building a diverse, inclusive, and authentic workplace. Candidates with transferable skills and relevant experience are encouraged to apply, even if their background does not perfectly align with every requirement.
SEO & GPT Optimization Keywords:
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