Position: Drug Surveillance Specialist
Location: Hyderabad, India
About the Role:
This role involves supporting the drug surveillance program, including follow-up activities, risk assessment, and evaluating the relatedness of adverse reaction reports. The individual will oversee safety in clinical trials and post-marketing programs, contribute to legal liability resolutions, and comply with governmental regulations. They will also assist in trending and safety signal detection, providing risk management assessments throughout the product life cycle, and offering safety support to clinical development teams.
Key Responsibilities:
Assist in the delivery of safety-related activities such as co-authoring safety documents, providing safety input for regulatory and clinical documents, and responding to Health Authority queries. Help monitor product safety profiles through literature reviews, medical evaluations of individual cases, and signal detection activities. Support the preparation of Health Authority queries, especially for urgent short-term requests, and manage follow-up activities related to Health Authority Assessment Reports. Assist in providing safety input for new indication submissions and other regulatory document safety inputs. Contribute to responses to internal and external safety requests. Act as a Subject Matter Expert (SME) for Medical Operations and the Medical Function, leading training and mentoring of junior colleagues.
Key Performance Indicators:
Timeliness and quality of safety analyses and presentations, compliance with internal and external regulations, and consistency and quality of safety deliverables.
Minimum Requirements:
Work experience in clinical research, clinical trials, safety science, and regulatory compliance. Expertise in managing people challenges, crises, and functional teams. Ability to collaborate across boundaries and manage projects efficiently. Strong skills in literature review, medical records management, and process safety.
Languages:
Fluent in English.
Why Novartis:
At Novartis, we are committed to reimagining medicine to improve and extend people’s lives. Our success comes from our community of smart, passionate individuals who collaborate to make breakthroughs that change patients' lives. Learn more about our mission and culture at Novartis Strategy.
Join Our Novartis Network:
Not the right role for you? Stay connected with us and explore future opportunities by signing up for our Novartis Network.
Benefits and Rewards:
Discover the ways we help our associates thrive professionally and personally in our Benefits Handbook.
Division: Development
Business Unit: Innovative Medicines
Location: Hyderabad, India
Company / Legal Entity: Novartis Healthcare Private Limited
Functional Area: Research & Development
Employment Type: Full-time, Regular
Shift Work: No
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji | Verna |Gujarat :
Ahmedabad | Baroda | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Alameda | Albion | Arcata | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redding | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | Stockton | Temecula | Thousand Oaks | Valencia | Vallejo | West Valley City | Whittier | Willits |Colorado :
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Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Jacksonville | Maitland | Miami | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta | Rome |Hawaii :
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Farmington | Santa Fe | Tucumcari |New York :
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Ambler | Collegeville | Harrisburg | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Spring House | West Chester | Wyomissing |Portugal :
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Mexico |South Carolina :
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Memphis | Nashville |Texas :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
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Frankfurt | Harveysburg |Lower Saxony :
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Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
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Kiel |BULGARIA :
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Dalian |Republic of China :
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Hangzhou |Cork :
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Swords |Dún Laoghaire :
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Haarlem |South Holland :
Leiden |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
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Sofia |Canada :
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Montreal |Chile :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |South Yorkshire :
Sheffield |United Kingdom :
Harlow | Salt Lake City | United Kingdom | Stirling | Maidenhead | Leeds | London |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Kfar Saba | Be'Er Sheva | Yavne | Netanya | Tel Aviv |Italy :
Italy |Lombardy :
Rho |Japan :
Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Remote | Switzerland | Remote - Middle East | Remote - Europe | Remote, USA |Bucharest :
Bucharest |Makkah :
Najran | Jeddah | Khulais | Rabigh | King Abdullah Economic City | Riyadh |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand |Brazil :
Sao paulo |South America :
Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |