Safety & Pv Specialist I (Icsr Processing)

Freshers years

3 LPA to 5 LPA

Gurgaon

20 Jan. 7, 2025

Job Description

Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D 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

Safety & Pharmacovigilance Specialist I (ICSR Processing)

Location: Gurugram, India | Job ID: 24006837 | Updated: Today

Join Syneos Health® – Pioneering Biopharmaceutical Solutions

Syneos Health is a globally recognized biopharmaceutical solutions provider. We specialize in accelerating customer success by seamlessly integrating clinical, medical affairs, and commercial insights. Our mission is to simplify and streamline processes to drive innovation and improve patient outcomes.

At Syneos Health, our employees are empowered to create meaningful change by delivering therapies that transform lives. With 29,000+ employees across 110 countries, we are dedicated to shaping a better future in healthcare.

Why Work at Syneos Health?

Career Development: Advance your career with comprehensive training, technical skill development, and opportunities for progression.
Inclusive Culture: Be your authentic self in a diverse and supportive environment with a focus on work-life balance.
Global Collaboration: Join a community where diverse perspectives fuel innovation.
Employee Recognition: Celebrate achievements through peer recognition and rewards programs.

Your Role as a Safety & Pharmacovigilance Specialist I

As a Safety & Pharmacovigilance Specialist I, you will contribute to global drug safety by processing Individual Case Safety Reports (ICSRs) while ensuring compliance with regulatory requirements. Your work will directly impact the safety and efficacy of therapies used worldwide.

Key Responsibilities:

Manage ICSR processing, including data entry, triage, coding, and narrative summary compilation.
Ensure regulatory compliance by maintaining safety tracking systems and conducting quality reviews.
Perform literature screening, MedDRA coding, and xEVMPD validation.
Support SPOR/IDMP activities and duplicate case management.
Collaborate with global teams to ensure accuracy in safety reporting.
Assist with Trial Master File (TMF) documentation for clinical trials.
Maintain up-to-date knowledge of global regulations, ICH GCP, and GVP guidelines.
Participate in audits and contribute to regulatory intelligence activities.

Qualifications

Essential Skills and Experience:

Bachelor’s degree in life sciences, pharmacy, nursing, or equivalent experience.
Strong knowledge of medical terminology and safety database systems.
Familiarity with clinical trial processes (Phases II-IV) and post-marketing safety requirements.
Proficiency in Microsoft Office Suite and safety reporting tools.
Exceptional organizational skills and attention to detail.

Preferred Attributes:

Strong communication skills (written and verbal).
Ability to work collaboratively in a fast-paced environment.
Proven problem-solving and multitasking capabilities.

Why Choose Syneos Health?

Global Impact: Work on groundbreaking projects—94% of Novel FDA Drugs and 95% of EMA-authorized products in the last five years.
Innovation at Scale: Be part of over 200 studies conducted across 73,000 sites and 675,000+ trial patients.
Professional Growth: Thrive in a competitive and rapidly evolving industry.

Apply Now

Become a part of Syneos Health’s mission to innovate and deliver life-changing therapies. Explore a role where your expertise makes a global impact.

Syneos Health is an equal opportunity employer. We are committed to inclusivity and providing reasonable accommodations under the Americans with Disabilities Act and other applicable regulations.

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Safety & Pv Specialist I (Icsr Processing)

Job Description

Safety & Pharmacovigilance Specialist I (ICSR Processing)

Join Syneos Health® – Pioneering Biopharmaceutical Solutions

Why Work at Syneos Health?

Your Role as a Safety & Pharmacovigilance Specialist I

Qualifications

Why Choose Syneos Health?

Apply Now

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