Safety Management Specialist
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-96578
About the Company
Lilly is a global healthcare leader committed to advancing innovative medicines and improving patient outcomes worldwide. Headquartered in Indianapolis, Indiana, we combine scientific expertise with a profound dedication to care. Our teams work across global markets to deliver life-changing therapies, enhance disease management, and support communities through strong corporate responsibility programs. We seek professionals driven by purpose and motivated to make a meaningful impact.
Role Overview
The Safety Management Specialist will support global pharmacovigilance operations by applying clinical judgment, regulatory expertise, and strong analytical skills to ensure the integrity, accuracy, and compliance of adverse event data across Lilly’s Global Patient Safety (GPS) systems. This role requires close collaboration with cross-functional teams, adherence to international regulatory requirements, and proactive participation in safety operations and system enhancements.
Key Responsibilities
Apply clinical judgment, critical thinking, and regulatory knowledge to manage adverse event data in GPS systems with a focus on accuracy, consistency, and compliance.
Continuously deepen understanding of Lilly products including clinical trial design, safety profile, regulatory obligations, identified risks, and associated risk minimization strategies.
Maintain updated knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, MHRA, PMDA) and their impact on case processing and expedited reporting.
Participate as a functional team member in assigned clinical study teams.
Support GPS-owned system operations (e.g., MOSAIC, LSS), including enhancements, updates, and workflow optimization.
Process adverse event reports from diverse sources including Clinical Trials, Patient Support Programs, literature, spontaneous reports, Lilly Market Research, and other relevant channels.
Assess safety reports for completeness, identify information gaps, and conduct necessary follow-ups to ensure robust documentation regarding seriousness, causality, expectedness, and case finalization.
Ensure timely adverse event data entry in alignment with internal and regulatory deadlines.
Lead or support updates to literature search strategies and resolution of safety system issues.
Translate global, regional, and local pharmacovigilance requirements into accurate expedited reporting rules.
Perform or verify MedDRA coding, review medical histories and concomitant medications, and ensure cases are prepared adequately for medical review.
Manage incoming workload proactively and collaborate with global teams to meet operational timelines.
Contribute expertise to local and global initiatives focused on innovation and quality improvement within Safety Management.
Maintain awareness of pharmacovigilance agreements for assigned products.
Minimum Qualifications
Master’s degree or equivalent, preferably in pharmaceutical sciences, biological sciences, or a related healthcare field.
Experience Required: Minimum 4 to 8 years of relevant professional experience in pharmacovigilance, safety case management, clinical research, or related domains.
Strong critical thinking and independent decision-making capabilities.
Ability to adapt to evolving electronic systems and processes.
Proficiency in basic computer applications including word processing, presentations, spreadsheets, databases, and online research tools.
Demonstrated ability to work effectively in diverse, global teams.
Fluency in English (written, spoken, and reading).
Equal Opportunity Commitment
Lilly is committed to fostering an inclusive workplace and providing equal employment opportunities. Accommodations are available for candidates with disabilities during the application process. For assistance, please submit an accommodation request using the official Lilly accommodation form.
Lilly maintains a strict non-discrimination policy across age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, disability, protected veteran status, and all other legally protected categories.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Almaty |Republic of Thailand :
Bangkok |Israel :
Be'Er Sheva | Yavne | Kfar Saba | Tel Aviv | Netanya |Remote :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
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