Syneos Health is inviting applications for the position of Safety & PV Specialist I – Literature Case Processing in Gurugram, India. This is an excellent opportunity for qualified M.Pharm, Pharm.D, BDS, or equivalent life sciences professionals with experience in literature data entry, medical literature monitoring, and pharmacovigilance case processing.
The selected candidate will support key drug safety and pharmacovigilance activities, including ICSR processing, literature screening, MedDRA coding, safety database entry, narrative writing, duplicate case management, quality review, and regulatory safety reporting.
Candidates with 2+ years of Literature Data Entry and Medical Literature Monitoring (MLM) experience are encouraged to apply.
About Syneos Health
Syneos Health is a leading fully integrated life sciences services organization supporting organizations across the drug development and commercialization lifecycle. The company works with pharmaceutical, biotechnology, and healthcare innovators to accelerate clinical development and improve patient outcomes.
The organization provides opportunities across clinical research, pharmacovigilance, regulatory operations, medical affairs, and other life sciences functions.
Job Details
- Company: Syneos Health
- Job Role: Safety & PV Specialist I – Literature Case Processing
- Department: Pharmacovigilance / Drug Safety
- Employment Type: Full-Time
- Work Type: Office-Based
- Location: Gurugram, India
- Experience Required: 2+ Years
- Qualification: M.Pharm / Pharm.D / BDS / Equivalent
- Job Category: Pharmacovigilance Jobs
- Job Requisition ID: 25111538
Key Responsibilities
As a Safety & PV Specialist I, you will support pharmacovigilance operations and literature case processing activities. Key responsibilities include:
- Entering and maintaining information in pharmacovigilance quality and tracking systems.
- Supporting the receipt, tracking, and processing of Individual Case Safety Reports (ICSRs).
- Triaging safety cases and evaluating ICSR data for completeness, accuracy, and regulatory reportability.
- Entering safety information into the designated safety database.
- Coding adverse events, medical history, concomitant medications, and laboratory tests.
- Preparing complete and accurate case narratives.
- Identifying missing information and following up on queries until resolution.
- Supporting timely and accurate expedited safety reporting according to regulatory requirements.
- Maintaining safety tracking activities for assigned projects.
- Performing medical literature screening and literature review for potential safety cases.
- Performing drug coding and maintaining drug dictionary information.
- Conducting MedDRA coding activities where required.
- Supporting validation and submission of xEVMPD product records.
- Coding indication terms using appropriate MedDRA terminology.
- Performing manual recoding of product and substance terms arising from ICSRs.
- Identifying and managing duplicate Individual Case Safety Reports.
- Supporting activities related to SPOR and IDMP requirements.
- Performing quality review of pharmacovigilance cases.
- Ensuring relevant documents are submitted to the Trial Master File (TMF) and Pharmacovigilance System Master File when applicable.
- Maintaining compliance with SOPs, Work Instructions, GCP, ICH guidelines, GVP, and applicable global regulations.
- Collaborating effectively with internal and external project team members.
- Participating in audits when required.
- Applying regulatory intelligence to pharmacovigilance and safety reporting activities.
Qualifications and Eligibility
Candidates applying for this Syneos Health Pharmacovigilance job in Gurugram should meet the following requirements:
Educational Qualification
Applicants should possess one of the following qualifications:
- M.Pharm
- Pharm.D
- BDS
- Equivalent relevant qualification
Experience
- Minimum 2+ years of experience in Literature Data Entry.
- Experience in Medical Literature Monitoring (MLM) is preferred.
- Experience in pharmacovigilance case processing is highly desirable.
Required Skills
The ideal candidate should have:
- Knowledge of pharmacovigilance and drug safety operations.
- Experience with safety databases and safety tracking systems.
- Knowledge of medical terminology.
- Understanding of ICSR processing and case management.
- Experience or knowledge of MedDRA coding.
- Understanding of literature screening and literature case processing.
- Knowledge of clinical trial processes across Phase II, Phase III, and Phase IV studies and/or post-marketing safety.
- Understanding of ICH GCP, GVP, and global pharmacovigilance regulations.
- Strong attention to detail and accuracy.
- Good written and verbal communication skills.
- Ability to manage multiple tasks and meet strict deadlines.
- Ability to work independently as well as collaboratively within a team.
- Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, Visio, and shared workspace tools.
Why Join Syneos Health?
Working at Syneos Health offers professionals an opportunity to contribute to global clinical development and drug safety programs.
Potential benefits and career advantages include:
- Career development and professional progression opportunities.
- Supportive line management and structured learning.
- Technical and therapeutic area training.
- Opportunities to work on global clinical and pharmacovigilance projects.
- Collaborative and inclusive work culture.
- Employee recognition programs.
- Competitive total rewards and benefits.
- Exposure to global drug development and regulatory environments.
Salary Expectation
The expected salary for a Safety & PV Specialist I – Literature Case Processing professional in Gurugram may vary depending on relevant experience, pharmacovigilance expertise, safety database knowledge, and company compensation policies.
Estimated Salary Range: ₹5,00,000 – ₹8,50,000 per annum.
Actual compensation may vary based on candidate experience and internal company policies.
Who Should Apply?
This opportunity is suitable for professionals searching for:
- Pharmacovigilance jobs in Gurugram
- Drug safety jobs in India
- Literature case processing jobs
- Medical Literature Monitoring jobs
- ICSR processing jobs
- Drug safety specialist jobs
- MedDRA coding jobs
- Pharmacovigilance jobs for M.Pharm
- Pharm.D pharmacovigilance jobs
- Safety database jobs in clinical research
- Syneos Health jobs in India
Candidates with hands-on experience in literature screening, MLM, ICSR case processing, adverse event coding, MedDRA coding, narrative writing, duplicate management, and safety database operations may find this role particularly relevant.
How to Apply?
