Syneos Health Hiring for Safety PV Specialist II for experienced pharmacovigilance professionals in literature and clinical trial case processing.
About the Company
Syneos Health is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success and improving patient outcomes worldwide. The company delivers comprehensive services across clinical development, medical affairs, and commercial solutions, helping pharmaceutical, biotechnology, and medical device organizations bring innovative therapies to market efficiently. Syneos Health Hiring for Safety PV Specialist II
With operations in more than 110 countries and a workforce of approximately 29,000 professionals, Syneos Health combines scientific expertise, operational excellence, and deep therapeutic knowledge. The organization has played a key role in the development of the majority of novel FDA-approved drugs and EMA-authorized products in recent years, supporting hundreds of clinical studies across thousands of research sites globally. Syneos Health Hiring for Safety PV Specialist II
Syneos Health is built on a strong people-centric culture. The company focuses on continuous learning, professional development, inclusion, and collaboration. Employees are encouraged to challenge conventional approaches, innovate with purpose, and contribute to meaningful work that directly impacts patient safety and public health. Syneos Health Hiring for Safety PV Specialist II
Job Details
- Job Title: Safety & PV Specialist II (Literature or Clinical Trial Case Processing)
- Job Requisition ID: 25104809
- Employment Type: Full Time
- Work Mode: Office-based
- Locations:
- Gurugram, India
- Hyderabad, India
- Pune, India
- Functional Area: Pharmacovigilance / Drug Safety
- Experience Required: Minimum 3.5 years
- Education Required: B.Pharm, M.Pharm, PharmD, or BDS
- Job Posting Status: Recently Posted
Job Description
Syneos Health is seeking an experienced Safety & PV Specialist II to support pharmacovigilance activities related to literature surveillance and clinical trial case processing. This role is designed for professionals with strong hands-on expertise in ICSR processing, regulatory compliance, and global safety reporting requirements. Syneos Health Hiring for Safety PV Specialist II
The Safety & PV Specialist II will play a critical role in ensuring the accurate, timely, and compliant processing of safety data across clinical trial and post-marketing programs. The position requires a solid understanding of pharmacovigilance regulations, medical terminology, and safety database systems, along with the ability to manage complex case workflows independently.
This role offers exposure to global pharmacovigilance operations, regulatory submissions, audits, and evolving safety standards, making it an excellent opportunity for professionals looking to advance their careers within a leading biopharmaceutical services organization. Syneos Health Hiring for Safety PV Specialist II
Key Responsibilities
- Enter and manage safety case information in pharmacovigilance quality and tracking systems for receipt, processing, and lifecycle management of ICSRs
- Process ICSRs in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), and project-specific safety management plans
- Triage incoming safety cases and evaluate data for completeness, accuracy, and regulatory reportability
- Perform detailed data entry into safety databases, including adverse events, medical history, concomitant medications, indications, and laboratory test results
- Code adverse events, medical terms, and product information using MedDRA and approved drug dictionaries
- Prepare high-quality narrative case summaries in line with regulatory expectations
- Identify missing, inconsistent, or unclear information and generate follow-up queries; ensure timely resolution of queries
- Support the preparation and submission of expedited safety reports in compliance with global regulatory timelines
- Maintain safety tracking logs, metrics, and documentation for assigned pharmacovigilance activities
- Conduct literature screening and review to identify potential safety cases
- Perform drug coding activities, maintenance of drug dictionaries, and MedDRA coding as required
- Validate and submit xEVMPD product records, including accurate coding of indication terms
- Perform manual recoding of un-recoded product and substance terms arising from ICSRs
- Identify, assess, and manage duplicate ICSRs to maintain data quality and compliance
- Support activities related to SPOR and IDMP requirements
- Perform quality review of safety cases to ensure compliance with internal standards and regulatory requirements
- Ensure all relevant safety documents are filed in the Trial Master File (TMF) for clinical trials and the Pharmacovigilance System Master File (PSMF) for post-marketing programs
- Maintain ongoing compliance with global safety regulations, including ICH-GCP, GVP, and applicable regional requirements
- Participate in internal and external audits and inspections as required
- Collaborate effectively with internal teams, sponsors, and external stakeholders to ensure smooth safety operations
Syneos Health Hiring for Safety PV Specialist II
Skills / Qualifications
Educational Qualifications
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm or M.Pharm)
- PharmD or BDS qualification is also acceptable
Syneos Health Hiring for Safety PV Specialist II
Experience Requirements
- Minimum 3.5 years of experience in pharmacovigilance or drug safety
- Mandatory experience in clinical trial case processing or literature case processing
- Strong working knowledge of global safety reporting requirements
Technical and Professional Skills
- Proficiency in pharmacovigilance safety databases and case processing workflows
- Strong knowledge of medical terminology and MedDRA coding
- Good understanding of clinical trial processes across Phases II to IV and post-marketing safety requirements
- Working knowledge of ICH-GCP, GVP guidelines, and safety regulations
- Experience with xEVMPD, SPOR, and IDMP activities is desirable
- Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, Outlook, and Visio
- Familiarity with shared content management systems and collaborative workspaces
Syneos Health Hiring for Safety PV Specialist II
Soft Skills
- Excellent written and verbal communication skills
- Strong organizational and time management abilities
- Ability to prioritize tasks and manage multiple projects simultaneously
- High attention to detail and commitment to data accuracy
- Ability to work independently as well as in cross-functional teams
Syneos Health Hiring for Safety PV Specialist II
Benefits / Perks
- Competitive compensation aligned with industry standards
- Opportunity to work on global pharmacovigilance programs
- Structured career development and internal growth opportunities
- Access to technical, therapeutic, and regulatory training programs
- Supportive leadership and collaborative work environment
- Inclusive workplace culture that values diversity and individual perspectives
- Exposure to international projects and regulatory agencies
- Long-term career stability with a globally recognized organization
Syneos Health Hiring for Safety PV Specialist II
Why You Should Join
Syneos Health offers a unique opportunity to build a long-term career in pharmacovigilance within a global, innovation-driven organization. Employees are empowered to take ownership of their work, continuously develop their skills, and contribute to patient safety on a global scale. Syneos Health Hiring for Safety PV Specialist II
The company’s Total Self culture encourages authenticity, collaboration, and professional growth. With exposure to complex safety cases, regulatory intelligence, and global stakeholders, this role provides an excellent platform for experienced PV professionals to strengthen their expertise and advance their careers. Syneos Health Hiring for Safety PV Specialist II
FAQs
Who is eligible to apply for this role?
Candidates with B.Pharm, M.Pharm, PharmD, or BDS qualifications and a minimum of 3.5 years of pharmacovigilance experience are eligible.
Is clinical trial or literature case processing mandatory?
Yes, hands-on experience in clinical trial or literature case processing is mandatory for this role.
What locations are available for this position?
This role is available in Gurugram, Hyderabad, and Pune.
Is this a remote job?
No, this is a full-time, office-based position.
What type of safety work will be handled?
The role involves clinical trial and literature safety case processing, expedited reporting, and regulatory compliance activities.
How to Apply
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
