Syneos Health Hiring Safety PV Specialist I in Gurugram and Hyderabad for experienced pharmacovigilance professionals.
About the Company
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success across the drug development lifecycle. With a strong presence across clinical development, medical affairs, and commercial services, Syneos Health partners with pharmaceutical, biotechnology, and medical device companies to bring innovative therapies to patients faster.
Over the past several years, Syneos Health has been involved in the majority of novel FDA-approved drugs and EMA-authorized products, supporting hundreds of clinical studies across thousands of trial sites globally. With a workforce of approximately 29,000 employees operating in more than 110 countries, the organization combines global scale with local expertise. Syneos Health Hiring Safety PV Specialist I
At Syneos Health, people are placed at the center of everything. The company’s culture emphasizes inclusion, professional growth, innovation, and accountability. Employees are encouraged to challenge the status quo, collaborate across functions, and contribute meaningfully to improving patient lives worldwide. Syneos Health Hiring Safety PV Specialist I
Job Details
- Job Title: Safety & PV Specialist I
- Job Requisition ID: 25104799
- Employment Type: Full Time
- Work Mode: Office-based
- Locations:
- Gurugram, India
- Hyderabad, India
- Pune, India
- Department: Pharmacovigilance / Drug Safety
- Experience Required: Minimum 2 years
- Education: B.Pharm, M.Pharm, PharmD, or BDS
Job Description
Syneos Health is hiring a Safety & PV Specialist I to support pharmacovigilance and drug safety operations across clinical trial and post-marketing programs. This role is ideal for professionals with hands-on experience in individual case safety report (ICSR) processing, literature review, and regulatory compliance within pharmacovigilance environments. Syneos Health Hiring Safety PV Specialist I
The selected candidate will be responsible for accurate and timely processing of safety data in accordance with global regulations, company SOPs, and project-specific safety management plans. The role requires strong attention to detail, sound medical knowledge, and the ability to collaborate with internal and external stakeholders.
This position offers an excellent opportunity to work in a global organization with exposure to complex safety projects, regulatory submissions, and evolving pharmacovigilance standards. Syneos Health Hiring Safety PV Specialist I
Key Responsibilities
- Enter and manage safety case information in pharmacovigilance quality and tracking systems for receipt and lifecycle management of ICSRs
- Process ICSRs in compliance with SOPs, work instructions, and project-specific safety plans
- Triage incoming ICSRs and assess data for completeness, accuracy, and regulatory reportability
- Perform data entry into safety databases, including adverse events, medical history, concomitant medications, and laboratory tests
- Code medical events and indications using MedDRA and WHO Drug Dictionary as applicable
- Prepare clear, concise, and compliant narrative case summaries
- Identify missing or unclear safety information and generate queries; follow up until satisfactory resolution
- Support timely preparation and submission of expedited safety reports to regulatory authorities
- Maintain safety tracking logs and metrics for assigned activities
- Conduct literature screening and review for identification of safety cases
- Support drug coding activities, dictionary maintenance, and recoding of un-recoded product or substance terms
- Identify and manage duplicate ICSRs to ensure data integrity
- Perform activities related to SPOR and IDMP compliance
- Validate and submit xEVMPD product records with appropriate MedDRA coding
- Conduct quality review of safety cases to ensure regulatory compliance
- Ensure submission of all relevant documents to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
- Maintain compliance with global regulations including ICH-GCP, GVP, and applicable safety reporting requirements
- Participate in audits and inspections as required
- Collaborate professionally with project teams, sponsors, and internal stakeholders
Syneos Health Hiring Safety PV Specialist I
Skills / Qualifications
Educational Qualifications
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm or M.Pharm)
- PharmD or BDS qualification is also acceptable
Experience Requirements
- Minimum 2 years of experience in pharmacovigilance or drug safety
- Preferred experience in clinical trial case processing or literature case processing
Technical and Professional Skills
- Strong knowledge of pharmacovigilance regulations and safety reporting requirements
- Good understanding of clinical trial processes across Phases II to IV and post-marketing safety
- Familiarity with safety databases and pharmacovigilance workflows
- Proficiency in MedDRA coding and medical terminology
- Working knowledge of ICH-GCP, GVP guidelines, and global regulatory requirements
- Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, Outlook, and Visio
- Ability to work with shared content management systems
Syneos Health Hiring Safety PV Specialist I
Soft Skills
- Excellent written and verbal communication skills
- Strong organizational and time management abilities
- High level of accuracy and attention to detail
- Ability to manage multiple tasks and meet deadlines
- Capability to work independently and as part of a team
Syneos Health Hiring Safety PV Specialist I
Benefits / Perks
- Competitive salary aligned with industry standards
- Exposure to global pharmacovigilance projects and regulatory submissions
- Structured career development and progression opportunities
- Technical and therapeutic area training programs
- Supportive and engaged line management
- Inclusive work culture that values diversity and individuality
- Opportunities to collaborate with international teams
- Stable and long-term career prospects within a global organization
Syneos Health Hiring Safety PV Specialist I
Why You Should Join
Joining Syneos Health means becoming part of an organization that is shaping the future of clinical research and drug safety. Employees are empowered to grow professionally while contributing to meaningful work that impacts patient safety worldwide.
The company fosters a culture where innovation, collaboration, and personal growth are encouraged. With exposure to cutting-edge therapies, global regulatory environments, and diverse projects, this role offers both stability and continuous learning for pharmacovigilance professionals. Syneos Health Hiring Safety PV Specialist I
If you are looking to advance your career in drug safety within a respected global organization, this role provides the right platform to build long-term expertise and professional credibility. Syneos Health Hiring Safety PV Specialist I
FAQs
Who can apply for this position?
Candidates with B.Pharm, M.Pharm, PharmD, or BDS qualifications and at least two years of pharmacovigilance experience can apply.
Is clinical trial experience mandatory?
Clinical trial case processing or literature case processing experience is preferred but not mandatory if strong PV knowledge is present.
What locations are available for this role?
This role is available in Gurugram, Hyderabad, and Pune.
Is this a remote position?
No, this is an office-based, full-time role.
What type of safety cases will I work on?
The role involves clinical trial and post-marketing safety cases, including expedited and non-expedited reporting.
Syneos Health Hiring Safety PV Specialist I
How to Apply
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