Syneos Health has opened a talent pipeline opportunity for Safety & PV Specialist – Future Roles in India. The position is listed for Hyderabad and Gurugram and follows a Hybrid work model.
This opportunity is suitable for candidates with a background in Life Sciences, Pharmacy or Nursing who are interested in Pharmacovigilance, Drug Safety and Clinical Safety.
Important: This is a future-role/talent pipeline posting, not a confirmed immediate vacancy. Candidates who express interest may be added to Syneos Health’s talent pipeline and considered if a suitable role becomes available.
Job Details
| Particulars | Details |
|---|---|
| Company | Syneos Health |
| Position | Safety & PV Specialist – Future Roles |
| Location | Hyderabad / Gurugram, India |
| Work Model | Hybrid |
| Employment Type | Full Time |
| Job ID | 25106956 |
| Experience | Relevant Safety/PV knowledge and experience preferred |
| Department | Pharmacovigilance / Drug Safety |
Job Description
The Safety & PV Specialist will support various pharmacovigilance and drug safety activities, including Individual Case Safety Report (ICSR) processing, safety database activities, literature screening, medical coding, quality review and regulatory safety reporting.
The role may involve working on clinical trial and post-marketing safety programs while following applicable SOPs, GCP, ICH, GVP and global drug, biologic and device regulations.
Key Responsibilities
- Enter and track information in PV quality and safety tracking systems.
- Assist with processing Individual Case Safety Reports (ICSRs) according to SOPs and project-specific safety plans.
- Triage ICSRs and review case information for completeness and accuracy.
- Enter case information into safety databases.
- Perform coding of events, medical history, concomitant medications and tests.
- Prepare complete narrative summaries.
- Identify missing information and raise queries for additional information.
- Follow up on queries until the required information is obtained and resolved.
- Assist with timely and accurate expedited safety reporting.
- Maintain safety tracking for assigned activities.
- Perform literature screening and review for safety-related information.
- Perform drug coding and maintain drug dictionaries as required.
- Perform MedDRA coding activities.
- Validate and submit xEVMPD product records.
- Perform manual recoding of un-recoded product and substance terms.
- Identify and manage duplicate ICSRs.
- Support SPOR / IDMP related activities.
- Perform quality review of ICSRs.
- Ensure relevant documents are submitted to the Trial Master File (TMF) and Pharmacovigilance System Master File as applicable.
- Follow company SOPs, work instructions, global regulations, GCP, ICH guidelines and GVP requirements.
- Participate in audits when required.
- Apply regulatory intelligence to safety reporting activities.
- Maintain professional communication with internal and external project teams.
Eligibility Criteria
Candidates should have:
- Bachelor’s degree in Life Science.
- Registered Nurse, Pharmacist or equivalent educational background may also be considered.
- Knowledge of safety database systems.
- Understanding of medical terminology.
- Knowledge of clinical trial processes across Phase II–IV and/or post-marketing safety requirements.
- Understanding of ICH GCP, GVP and Pharmacovigilance regulations.
Required Skills
- Pharmacovigilance
- Drug Safety
- ICSR Processing
- Safety Database
- MedDRA Coding
- Medical Terminology
- Literature Screening
- Clinical Trial Safety
- Post-Marketing Safety
- GCP
- GVP
- ICH Guidelines
- SPOR / IDMP
- xEVMPD
- Microsoft Word, Excel and PowerPoint
- Good communication skills
- Strong organizational skills
- Attention to detail
- Ability to manage multiple tasks and deadlines
Work Location
The position is associated with the following locations:
- Hyderabad, India
- Gurugram, India
Work Model: Hybrid
Important Note for Candidates
Syneos Health has specifically stated that this posting is intended for a possible upcoming opportunity rather than a currently available live role.
By expressing interest, candidates may be added to the company’s talent pipeline and considered if this type of position becomes available in the future.
Therefore, candidates should not consider this posting as confirmation of an immediate job opening.
How to Apply
Interested candidates can express their interest through the official Syneos Health careers portal.
Company: Syneos Health
Position: Safety & PV Specialist – Future Roles
Job ID: 25106956
Locations: Hyderabad / Gurugram
Work Model: Hybrid
Employment Type: Full Time
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