Associate Safety Data Management Specialist
Location: India – Chennai
Job Type: Full-Time
Experience Required: 0–2 Years
Work Mode: Hybrid
Job ID: 4953942
Overview
Join a global leader in healthcare innovation as an Associate Safety Data Management Specialist, where you will contribute to advancing patient safety through robust pharmacovigilance and safety data management practices. This role is ideal for early-career professionals seeking to build expertise in drug safety, regulatory compliance, and clinical data analysis within a structured and high-impact environment.
Key Responsibilities
You will be responsible for supporting drug safety surveillance activities across clinical trials and post-marketing programs. The role involves intake, evaluation, and processing of adverse event reports while ensuring compliance with global regulatory standards. You will perform Individual Case Safety Report (ICSR) processing using safety databases such as ARGUS, including case validation, duplicate checks, data entry, coding, causality assessment, and narrative writing.
Additionally, you will review medical literature and post-marketing data to support safety signal detection and regulatory strategy. You will follow defined workflows and standard operating procedures to ensure accuracy, completeness, and timely submission of safety data. Collaboration with cross-functional teams, including regulatory and medical affairs, will be essential to support safety reporting and compliance activities.
Education and Qualification Requirements
Candidates must hold a Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm) or a Pharm.D.
Experience Requirements
0 to 2 years of experience in pharmacovigilance, drug safety, or related domains is required. Freshers with relevant academic exposure may also be considered.
Required Skills and Competencies
Strong attention to detail and accuracy in data handling
Good analytical and problem-solving abilities
Effective written and verbal communication skills
Understanding of pharmacovigilance principles and regulatory requirements
Ability to work collaboratively in a team-oriented environment
Commitment to continuous learning and professional development
Preferred Qualifications
Certification or coursework in pharmacovigilance or drug safety
Familiarity with global safety regulations and medical terminology
Experience with safety databases such as ARGUS
Exposure to AI tools or digital technologies supporting data analysis and productivity improvements
Why Join
This role offers an excellent opportunity to build a career in pharmacovigilance within a globally recognized pharmaceutical environment. You will gain hands-on experience in safety data management, regulatory compliance, and advanced drug safety systems while contributing to improving patient outcomes worldwide.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Netherlands |Remote Australia :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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