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Safety & PV Specialist & Safety Data Coordinator Jobs

Join Syneos Health: Shape the Future of Pharmacovigilance in India

Summary: Syneos Health, a leading global healthcare organization, is seeking motivated and experienced professionals to join our Pharmacovigilance (PV) teams in Hyderabad and Gurgaon. We are currently hiring for two key positions: Safety & PV Specialist I and Safety Data Coordinator (SDC). These roles offer exceptional opportunities for career advancement, hands-on experience with global projects, and a collaborative, supportive work environment. If you possess a strong background in ICSR case processing and a passion for patient safety, we encourage you to apply.

About Syneos Health:

Syneos Health is a fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes—to speed the delivery of important therapies to patients. Our innovative solutions are designed to help biopharmaceutical companies navigate an increasingly complex landscape, drive better decision-making, and ultimately, improve global health.

We are currently recruiting for the following positions:

1. Safety & PV Specialist I

Role Overview:

As a Safety & PV Specialist I, you will be responsible for the end-to-end processing of Individual Case Safety Reports (ICSRs). This includes case booking, triage, review, data entry, and ensuring compliance with global regulatory guidelines and internal standard operating procedures (SOPs). You will work closely with a team of experienced PV professionals, contributing to the safety surveillance of pharmaceutical products and contributing to the well-being of patients worldwide.

Key Responsibilities:

  • Process ICSRs from various sources, including spontaneous reports, clinical trials, and literature.
  • Perform case booking, triage, and thorough review of safety information.
  • Accurately enter data into safety databases (Argus Safety Database, Aris-G, or LifeSphere Multi-Vigilance (LSMV)).
  • Ensure timely and accurate submission of safety reports to regulatory authorities.
  • Maintain a strong understanding of medical terminology and pharmacovigilance regulations.
  • Collaborate with team members and contribute to a positive and efficient work environment.
  • Participate in training programs and continuous learning to stay updated on industry best practices.

Qualifications & Experience:

  • Experience: 2.6 to 4 years of experience in ICSR case processing. Experience with spontaneous reports, clinical trial reports, or literature cases is highly desirable.
  • Technical Skills: Hands-on experience with Argus Safety Database, Aris-G, or LifeSphere Multi-Vigilance (LSMV) is essential. Expertise in case booking, triage, review, and data entry within these systems is required.
  • Education: B.Pharm, M.Pharm, Pharm D, BDS, BMS, or MBBS degree.
  • Skills: Strong communication skills (both written and verbal), a solid understanding of medical terminology, and the ability to work independently and as part of a team.
  • Ineligible: BSc, MSc degrees.

2. Safety Data Coordinator (SDC)

Role Overview:

As a Safety Data Coordinator (SDC), you will be responsible for ensuring the accurate and efficient data entry and processing of ICSRs. Your primary focus will be on data entry and maintaining the integrity of safety information within the designated safety databases. This role requires a keen eye for detail, a strong understanding of medical terminology, and the ability to work within established procedures.

Key Responsibilities:

  • Perform accurate and timely data entry of safety information into the Argus Database, Aris-G, or LifeSphere Multi-Vigilance (LSMV).
  • Ensure data quality and consistency within the safety databases.
  • Collaborate with senior team members to resolve data discrepancies.
  • Maintain a thorough understanding of medical terminology and safety reporting guidelines.
  • Adhere to established SOPs and regulatory requirements.
  • Participate in training programs and continuous learning to enhance skills and knowledge.

Qualifications & Experience:

  • Experience: 1 to 2.6 years of experience in ICSR case processing with a focus on data entry.
  • Technical Skills: Experience with Argus Database, Aris-G, or LifeSphere Multi-Vigilance (LSMV) is required.
  • Education: B.Pharm, M.Pharm, Pharm D, BDS, BMS, or MBBS degree.
  • Skills: Strong data entry skills, a solid understanding of medical terminology, and the ability to work independently and accurately.
  • Ineligible: BSc, MSc degrees.

Why Join Syneos Health?

  • Global Exposure: Work with a global PV team and gain experience on international projects.
  • Career Growth: Benefit from excellent career growth opportunities within a dynamic and expanding organization.
  • Training & Development: Access continuous training and learning programs to enhance your skills and knowledge.
  • Collaborative Environment: Thrive in a supportive, collaborative work environment where your contributions are valued.

Job Locations:

  • Hyderabad
  • Gurgaon (Gurugram)

How to Apply:

If you are a motivated and experienced professional seeking a challenging and rewarding career in pharmacovigilance, we encourage you to apply.

Please send your updated resume to [email protected].

Important: Please mention the position you are applying for (Safety & PV Specialist I or Safety Data Coordinator) in the subject line of your email.

We look forward to hearing from you!