Safety & PV Submission Specialist II Job at Syneos Health – Gurugram / Hyderabad

Syneos Health is hiring a Safety & PV Submission Specialist II for its Pharmacovigilance team in Gurugram or Hyderabad (Hybrid). This is a strong pharma jobs opportunity for experienced professionals in safety reporting and regulatory submissions to advance their pharmaceutical careers in India.

About the Company

Syneos Health is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success from clinical development to commercialization. With deep expertise across the drug development continuum, Syneos Health partners with innovators to navigate complexity and deliver therapies faster.

The company is known for innovation, regulatory excellence, and a strong commitment to diversity, inclusion, and employee development, operating globally with a passionate, purpose-driven workforce.

Job Details

• Company Name: Syneos Health
• Experience: Minimum 4 Years in Safety & Pharmacovigilance (including safety submissions)
• Qualification: Bachelor’s Degree in Life Sciences, Registered Nurse, Pharmacist, or equivalent
• Location: Gurugram / Hyderabad (Hybrid)
• Work Type: Hybrid

Job Description

Syneos Health is looking for an experienced Safety & PV Submission Specialist II to support expedited and periodic safety reporting activities. The role involves collaboration with sponsors, preparation of safety documents, regulatory submissions, and ensuring compliance with global pharmacovigilance requirements. This position is ideal for professionals seeking growth in clinical safety and regulatory operations within a dynamic life sciences environment.

Safety & PV Submission Specialist II

• Department: Safety & Pharmacovigilance
• Role: Safety & PV Submission Specialist II
• Experience: Minimum 4 Years
• Education/Qualification: Bachelor’s Degree in Life Sciences, Registered Nurse, Pharmacist, or equivalent

Skills/Qualifications

• Strong experience in safety submissions to regulatory authorities
• Knowledge of PV guidelines (EMA, FDA, India, ICH-GCP, GVP)
• Proficiency in safety database systems and medical terminology
• Experience with TMF filing and oversight
• Excellent organizational, communication, and interpersonal skills
• Ability to work independently and manage multiple tasks

Key Responsibilities

• Prepare and assemble expedited and periodic safety reports
• Maintain tracking of safety submissions and provide status updates
• Apply regulatory intelligence to all safety reporting activities
• File documents in Trial Master File (TMF) and Pharmacovigilance System Master File
• Support project launch and internal review meetings
• Participate in audits and ensure compliance with SOPs and regulations

Benefits/Perks

• Career growth in a global life sciences leader
• Exposure to diverse clinical and post-marketing safety projects
• Continuous learning and development programs
• Collaborative and inclusive work culture
• Competitive total rewards and recognition

How to Apply

Verified Post

Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Syneos Health career page.

Interested candidates can apply directly through the Syneos Health career portal using Job ID 25108530.

For more pharma jobs and opportunities across India, visit Pharma Recruiter.

Apply now and advance your pharmacovigilance career with Syneos Health!

Walk-in Interview Details

Not applicable (Standard application process)

Why You Should Join

Syneos Health offers a dynamic, purpose-driven culture where innovation and collaboration thrive. The company provides long-term career stability, recognition for contributions, and continuous learning opportunities in a global environment. With a strong focus on regulatory excellence and patient impact, joining Syneos Health means working on meaningful projects that accelerate the delivery of life-changing therapies while building a rewarding career in pharmacovigilance and safety operations.

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