PHARMAFull-time
Safety & PV Coordinator
By Admin · Pharmacovigilance & Drug Safety
HYDERABAD (IN)ONSITEPOSTED: 9/9/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE OVERVIEW
Join Syneos Health as a Safety & PV Coordinator in Hyderabad to handle end-to-end ICSR management and regulatory compliance. Play a pivotal role in post-marketing surveillance and global patient safety operations.
ROLE DEFINITION & RESPONSIBILITIES
- •Triage and process ICSRs according to standard SOPs and safety management plans
- •Enter data, code adverse events, medical history, and concomitant medications into safety database
- •Write and compile clear, standardized narrative summaries
- •Identify and resolve case queries through proactive data follow-ups
- •Perform literature screening, MedDRA coding, and drug dictionary maintenance
- •Validate and submit xEVMPD product records and participate in SPOR/IDMP tasks
- •Maintain documentation in Trial Master Files (TMF) and Pharmacovigilance System Master Files (PSMF)
- •Perform quality checks and duplicate evaluations across spontaneous and PMS cases
Reporting Hierarchy: Reports to PV Operations Team Lead / Manager • Team size: 10-15
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- B.Pharm or M.Pharm degree
- Minimum 1 year of experience handling PMS and spontaneous cases
- Proficiency with safety database systems (Argus Safety or LSMV)
- Strong understanding of medical terminology, ICH-GCP, and GVP guidelines
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook)
PREFERRED QUALIFICATIONS
- •Hands-on experience with xEVMPD validation and SPOR/IDMP standards
- •Experience with literature review and global regulatory submission frameworks
- •Proven track record in rapid case turnaround and audit readiness
REQUIRED VERIFIED SKILLS
Pharmacovigilance
ICSR Processing
Argus Safety
LSMV
MedDRA
GVP
ICH-GCP
Post-Marketing Surveillance (PMS)
Narrative Writing
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Comprehensive health coverage, life insurance, retirement/PF contributions, paid time off, and continuous professional development programs.
Salaries for PV professionals with 1-2 years of experience in Hyderabad typically range from INR 3,50,000 to INR 5,50,000 annually depending on domain knowledge and database expertise.
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a fully-integrated life sciences services organization driving drug development and commercialization across global markets. Over the last five years, Syneos Health has contributed to 94% of novel FDA-approved drugs and 95% of EMA-authorized products.
TEAM SIZE: 10,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
Culture: Syneos Health fosters a 'Driven to Deliver' mindset prioritizing authenticity, collaborative problem-solving, and direct impact on patient health.
EXPECTED CAREER ROADMAP
Offers a defined progression track from Safety & PV Coordinator to Senior PV Specialist, Safety Team Lead, and Safety Operations Management.
APPLICATION ADVISORY
Highlight practical case-processing experience with Argus or LSMV, narrative drafting accuracy, and your immediate joining availability directly in your resume.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.