Safety & Pv Specialist Il (Mis)

0-2 years

Not Disclosed

Gurugram

10 Nov. 3, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Safety & PV Specialist II (MIS)

Location: Gurugram, India
Job ID: 25999948
Updated On: October 30, 2025
Category: Pharmacovigilance / Drug Safety
Company: Syneos Health®
Employment Type: Full-time

Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. The company integrates clinical development, medical affairs, and commercial expertise to deliver efficient and innovative biopharma solutions worldwide.

With operations in 110 countries and a workforce of 29,000+ employees, Syneos Health works on advancing modern market realities by keeping patients and customers at the center of everything they do.

Key Achievements:

Partnered in 94% of all FDA-approved novel drugs in the past five years.
Supported 95% of EMA-authorized products.
Contributed to over 200 clinical studies across 73,000 sites and 675,000+ trial patients.

Work Philosophy

At Syneos Health, work is driven by the belief that “Work Here Matters Everywhere.”
Employees are encouraged to:

Take initiative and challenge the status quo.
Collaborate with cross-functional global teams.
Innovate continuously in a fast-evolving healthcare environment.

Culture & Values

Total Self Culture — where every employee can bring their authentic self to work.
Syneos Health fosters an inclusive, diverse, and supportive environment emphasizing:

Career growth and development opportunities.
Technical and therapeutic training across various domains.
Engaged leadership and peer recognition.
Diversity of thought leading to collective innovation and belonging.

Role Summary

The Safety & PV Specialist II (MIS) plays a key role in Pharmacovigilance (PV) and Safety Monitoring, ensuring the collection, management, and analysis of safety data to protect patient well-being and ensure regulatory compliance.
This position is part of the Medical Information & Safety (MIS) department, which supports the broader clinical development process.

Key Responsibilities

(Indicative, as full task details are not disclosed in the job listing)

Participate in pharmacovigilance operations and safety data review.
Maintain and update safety databases with high data accuracy.
Support case processing, medical review, and regulatory reporting activities.
Contribute to signal detection and risk management processes.
Collaborate with global PV teams to ensure compliance with ICH-GCP and global regulatory standards.
Support management in generating Safety Management Reports and MIS analytics.

Candidate Profile

Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or related field.
Experience: Prior experience in pharmacovigilance or safety operations preferred.
Skills:
- Strong understanding of drug safety principles and PV regulations.
- Proficiency in Microsoft Office tools and data reporting systems.
- Excellent communication and documentation abilities.
- Ability to work independently and within a team-based environment.

Why Join Syneos Health

Be part of a global organization that impacts millions of patients’ lives.
Access continuous training and career progression pathways.
Collaborate with global experts in clinical research and pharmacovigilance.
Work in an environment that values diversity, inclusion, and authenticity.

Additional Information

The company may assign additional tasks based on business requirements.
Syneos Health ensures compliance with local and international labor laws, including the EU Equality Directive and Americans with Disabilities Act (ADA).
Reasonable accommodations are provided when appropriate.
Employment terms are non-contractual and may vary depending on project or region.

Application Details

🔗 Apply Online: www.syneoshealth.com
Or Join the Talent Network to stay informed about future opportunities.

Equal Opportunity Statement

Syneos Health is an Equal Opportunity Employer, committed to building a workplace where everyone feels valued and respected regardless of race, color, gender, religion, disability, sexual orientation, or national origin.

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