Join Syneos Health and Advance Your Pharmacovigilance Career in India
Summary:
Syneos Health, a leading global clinical research and biopharmaceutical organization, is seeking talented and motivated individuals to join our dynamic pharmacovigilance team in India. We have two exciting full-time, office-based positions available in Hyderabad and Gurugram: Safety Specialist I (Hyderabad) and Safety & PV Specialist II (Literature Review) (Hyderabad/Gurugram). These roles offer exceptional opportunities to contribute to global drug safety operations, gain exposure to ICH-GCP, GVP, ICSRs, MedDRA coding, and real-world safety databases, all while building a rewarding career in pharmacovigilance.
Job Opportunities:
1. Safety Specialist I – Hyderabad
Role Overview:
As a Safety Specialist I, you will be responsible for processing and tracking Individual Case Safety Reports (ICSRs) and ensuring adherence to pharmacovigilance regulations. You will be working in a fast-paced environment, contributing to the safety of patients worldwide.
Key Responsibilities:
- Process and track Individual Case Safety Reports (ICSRs) efficiently and accurately.
- Perform MedDRA coding, ensuring accurate and consistent application of the terminology.
- Write clear and concise narrative summaries of ICSRs.
- Resolve queries related to ICSRs in a timely and professional manner.
- Conduct literature screening to identify potential safety concerns.
- Perform drug coding.
- Validate and submit xEVMPD product records.
- Identify duplicate ICSRs and take appropriate action.
- Ensure regulatory reporting compliance according to applicable guidelines and regulations.
- Maintain proper documentation in the Trial Master File (TMF).
- Support audits and maintain compliance with Standard Operating Procedures (SOPs), Good Pharmacovigilance Practices (GVP), and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice (ICH-GCP) guidelines.
Required Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
- A foundational understanding of pharmacovigilance regulations and safety reporting requirements.
- Knowledge of safety databases, MedDRA coding principles, GCP, and GVP guidelines.
- Excellent communication, attention to detail, and organizational skills.
2. Safety & PV Specialist II (Literature Review) – Hyderabad / Gurugram
Role Overview:
As a Safety & PV Specialist II specializing in literature review, you will play a crucial role in identifying and evaluating safety information from scientific literature to support pharmacovigilance activities. Your expertise will contribute to the timely detection and management of potential safety risks.
Key Responsibilities:
- Conduct comprehensive global and local literature searches using databases such as Embase, PubMed, and Medline.
- Extract and summarize safety-relevant data from publications.
- Process literature-driven ICSRs and write detailed narrative summaries.
- Validate search strategies to ensure alignment with GVP Module VI requirements.
- Support audit readiness by maintaining accurate documentation and adhering to SOPs.
- Ensure compliance with TMF documentation requirements.
- Collaborate with data management teams to ensure data reconciliation and accuracy.
Required Qualifications:
- Bachelor’s or Postgraduate degree in Pharmacy, Life Science, Nursing, or a related field.
- Minimum of 3.5 years of pharmacovigilance experience.
- Demonstrated experience in literature review for safety case processing.
- Mandatory and in-depth knowledge of GVP Module VI.
Why Choose Syneos Health?
At Syneos Health, we are committed to fostering a supportive and rewarding work environment where our employees can thrive. We offer:
- Career Growth and Mentorship: Opportunities for professional development and mentorship to support your career aspirations.
- Global Project Exposure: The chance to work on diverse and impactful projects on a global scale.
- Total Rewards Recognition Program: A comprehensive program that recognizes and rewards outstanding contributions.
- Supportive and Diverse Work Culture: A collaborative and inclusive environment where diversity is valued.
- Opportunity to Work on FDA & EMA Submissions: Gain valuable experience in preparing and submitting regulatory documents to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Job Locations:
- Safety Specialist I: Hyderabad (Office-based)
- Safety & PV Specialist II: Hyderabad / Gurugram (Office-based)
Application Instructions:
If you are a motivated and skilled professional seeking a challenging and rewarding career in pharmacovigilance, we encourage you to apply.