Senior Medical Safety Advisor
Bengaluru, India (Home-based)
Job available in additional locations
Full-time
R1492668
The Senior Medical Safety Advisor provides advanced medical expertise in evaluating safety data from various sources throughout the pharmacovigilance lifecycle. The role focuses on assessing serious adverse event (SAE) reports in the context of the product’s safety profile and therapeutic area. As a senior technical leader, this position also contributes to signal detection, aggregate report preparation, audits, and training, while supporting safety surveillance activities for assigned products.
Perform medical review of:
Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
Narrative content, seriousness, expectedness, causality, and coding (e.g., MedDRA)
Compose and medically review Analyses of Similar Events (AOSE) for expedited regulatory reporting.
Review coding for AEs, SAEs, SADRs, medical history, and concomitant medications.
Conduct medical safety reviews of:
Clinical study protocols
Investigator Brochures (IBs)
Case Report Forms (CRFs)
Safety plans and medical monitoring plans
Contribute to or review:
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Other regulatory or ad hoc aggregate safety reports
Monitor safety trends from post-marketing data, literature, and observational studies.
Support signal detection efforts and safety strategy discussions.
Serve as Lead Safety Physician, team support, or back-up as required.
Provide therapeutic area and pharmacovigilance guidance to safety team members handling case assessments.
Ensure timely delivery of medical safety services and compliance with regulatory and contract timelines.
Act as a safety representative in internal/external meetings, including client discussions.
Lead or support training, audits, product transitions, and knowledge-sharing sessions.
Provide 24/7 medical escalation support for:
Medical information services
EU QPPV (Qualified Person for Pharmacovigilance) projects
Maintain up-to-date knowledge of evolving medical and regulatory safety standards.
| Requirement | Details |
|---|---|
| Education | Medical degree from an accredited and internationally recognized medical school (Required) |
| Clinical Experience | Minimum 3 years of clinical medical practice post-degree (Residency/graduate medical training may be considered) |
| Industry Experience | At least 2 years of experience in the pharmaceutical industry (Preferred) |
| Medical Knowledge | Strong understanding of general medicine and therapeutic areas |
| Regulatory Knowledge | In-depth knowledge of GCP, ICH guidelines, and global pharmacovigilance regulations |
| Safety Systems | Proficiency in safety databases and pharmacovigilance systems |
| Computer Skills | Proficient in Microsoft Word, Excel, PowerPoint |
| Soft Skills | Strong verbal and written communication; ability to work with cross-functional teams and external stakeholders |
| Licensure | Valid medical license in the country/region of residence (Preferred) |
IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services. We empower healthcare organizations with the tools and expertise to innovate and improve outcomes for patients worldwide by intelligently connecting data, technology, and deep domain knowledge.
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Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Mangaluru | Mysore | Udupi |Kerala :
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Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
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Birmingham |Alaska :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
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Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Basel | Zurich |Carlow :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
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Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
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Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
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Sofia |Canada :
Canada |Ontario :
North York | Richmond Hill | Renfrew | Mississauga | Australia | Uxbridge |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Athens | Koropi |Greece :
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Surabaya |Jakarta :
Jakarta |Israel :
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Italy |Lombardy :
Rho |Japan :
Japan | Saitama |Tokyo :
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Almaty |Remote Korea :
Remote Korea |Republic of Korea :
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Kuala Lumpur |Mexico :
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Lima |Cebu Province :
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Remote - Africa | Remote - Middle East | McFarland | Riga | Remote | Hammond | Medan | Bishop | Remote - Europe | Hungary | Green Way | Manipal | Lenexa | Faridabad | Leinster | Melbourne | Belgium | French | Nairobi | Castlebar | Switzerland | Thailand | Xzagreb | Minnesota | Zaragoza | Remote - South America (Latin Americal) | Victoria | Blue Bell | Bountiful | Texas | Ireland | Springville | Remote, USA | Tulsa | Slovakia | Lousiana |Bucharest :
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Najran | Rabigh | Jeddah | Khulais | Riyadh | King Abdullah Economic City |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand | South Africa |Brazil :
Sao paulo | Brazil |South America :
Peru | Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
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Kyiv |Dubai :
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HÃ Ná»™i | Hanoi |Ho Chi Minh :
Ho Chi Minh City |