Safety Specialist II – Clinical Trials (Hybrid, Hyderabad, India)
Location: Hyderabad, India (Hybrid)
Job ID: 25102440
Updated: October 31, 2025
Experience Required: 4–7 years in Pharmacovigilance and Clinical Trial Safety
About Syneos Health
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating clinical and commercial success. We convert complex clinical, medical affairs, and commercial insights into actionable outcomes, addressing modern healthcare challenges.
Our Clinical Development model places patients and customers at the center of every process. By simplifying workflows and fostering innovation, Syneos Health ensures a collaborative and impactful environment for employees and clients alike.
Role Overview
The Safety Specialist II – Clinical Trials is responsible for supporting pharmacovigilance and safety management activities across clinical studies. The role requires expertise in ICSR processing, safety data management, and regulatory compliance. The specialist will ensure patient safety, accurate reporting, and adherence to global safety standards.
This is a hybrid role based in Hyderabad, ideal for candidates with proven clinical trial safety experience and a strong understanding of GVP, ICH-GCP, and local regulatory requirements.
Key Responsibilities
Review, process, and manage Individual Case Safety Reports (ICSRs) from clinical trials in compliance with SOPs and regulatory requirements.
Evaluate ICSR data for completeness, accuracy, and reportability, ensuring timely entry into safety databases.
Perform triaging, medical coding (MedDRA), and narrative preparation for safety events.
Support expedited reporting and safety signal detection for clinical trials.
Maintain safety tracking and monitoring of ongoing clinical trial activities.
Assist in TMF documentation related to pharmacovigilance activities.
Perform literature review for safety signals and manage duplicate case identification.
Support regulatory submissions and ensure compliance with local and global safety regulations.
Collaborate with cross-functional teams including clinical operations, medical affairs, and regulatory teams.
Participate in audits, inspections, and follow-up activities, ensuring safety compliance readiness.
Qualifications & Experience
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Medicine, or related field (B. Pharm, M. Pharm, BDS, MBBS preferred; BSc/MSc not eligible).
4–7 years of experience in clinical trial safety, pharmacovigilance, or ICSR processing.
Hands-on experience with safety databases such as Argus or ArisG.
Strong understanding of GVP, ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
Excellent attention to detail, analytical skills, and communication abilities.
Ability to work in a hybrid environment, collaborating across teams and time zones.
Why Join Syneos Health?
Be part of a global workforce of 29,000 employees across 110 countries.
Contribute to clinical trials impacting 94% of FDA-approved novel drugs and 95% of EMA-authorized products in recent years.
Access professional development programs, mentorship opportunities, and career progression paths.
Thrive in an inclusive workplace culture that values diversity, collaboration, and innovation.
Additional Information
Tasks and responsibilities listed are not exhaustive; the company may assign additional duties as needed.
Equivalent experience and education will be considered.
Compliance with global employment legislation and ADA accommodations will be provided as applicable.
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Arkansas | Remote Australia |New South Wales :
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McFarland | Green Way | Springville | Nairobi | Remote - South America (Latin Americal) | French | Melbourne | Remote, USA | Zaragoza | Medan | Lenexa | Switzerland | Remote - Africa | Bountiful | Remote | Castlebar | Leinster | Bishop | Lousiana | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Texas | Riga | Faridabad | Remote - Europe | Belgium | Tulsa | Minnesota | Ireland | Remote - Middle East | Hammond | Manipal | Slovakia | Victoria | Blue Bell | Xzagreb |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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Niš |Bohemia :
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