Job Title: Senior Pharmacovigilance Reporting Associate
Locations:
Chennai, India
Trivandrum, India
Bangalore, India
Work Type: Office with Flex / Remote
Employment Type: Full-time
Job Requisition ID: JR133444
Posted: 7 days ago
Company Overview – ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence. ICON’s mission is to shape the future of clinical development by providing high-quality solutions and advancing patient outcomes.
Role Overview
As a Senior Pharmacovigilance Reporting Associate, you will play a critical role in ensuring accurate and timely reporting of safety data related to pharmaceutical products. You will collaborate with cross-functional teams to enhance pharmacovigilance reporting processes and ensure compliance with regulatory standards.
Key Responsibilities
Prepare and submit adverse event reports and safety data in accordance with regulatory requirements and internal policies, ensuring accuracy and completeness.
Collaborate with clinical and regulatory teams to review and analyze safety data, identifying trends and potential safety signals.
Assist in preparing periodic safety update reports (PSURs), annual reports, and other regulatory documents.
Monitor timelines for safety report submissions and proactively manage delays or issues.
Maintain and update pharmacovigilance databases, ensuring data integrity and quality.
Train and support junior team members on reporting procedures and regulations.
Participate in audits and inspections by regulatory authorities, ensuring compliance with all reporting requirements.
Stay informed on changes in regulatory guidelines and industry standards to maintain best practices in pharmacovigilance reporting.
Required Qualifications & Skills
Education: Bachelor’s degree in Life Sciences, Pharmacy, or related field (Advanced degree preferred)
Experience: Extensive experience in pharmacovigilance or drug safety reporting
Strong knowledge of regulatory requirements and pharmacovigilance guidelines
Proven ability to prepare and submit accurate adverse event reports on time
Strong analytical skills to interpret safety data and identify trends
Excellent communication and interpersonal skills
Proficiency in pharmacovigilance databases, reporting tools, and Microsoft Office Suite
Ability to manage multiple projects in a fast-paced environment with attention to detail
Commitment to confidentiality and handling sensitive patient information
What ICON Offers
Competitive salary with additional benefits focused on well-being and work-life balance
Examples of benefits:
Various annual leave entitlements
Health insurance for you and your family
Competitive retirement planning options
Global Employee Assistance Programme (24/7 support via TELUS Health)
Life assurance
Flexible optional benefits: childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments
Diversity & Inclusion
ICON is committed to an inclusive and accessible environment.
Workplace free from discrimination and harassment.
Equal employment consideration for all candidates regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Reasonable accommodations provided for medical conditions or disabilities during application or employment.
Application Note
Candidates who do not meet all requirements are still encouraged to apply. ICON values diverse experiences and skills.
Current ICON employees should apply via internal channels.
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Wilmington |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Georgia :
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Hilo | Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Kington :
Frank Scottile Blvd |LA :
Baton Rouge | Monroe | New Orleans |Louisiana :
Lake Charles | Shreveport |Maine :
Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
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Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
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Mexico |South Carolina :
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Knoxville | Memphis | Nashville |Texas :
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Hawai | kentucky | Sylmar | Woonsocket |Virginia :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
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Germany | GErmany |Hesse :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
Wavre |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
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Basel | Zurich |Carlow :
Carlow |Cork :
Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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Donegal |China :
China | Quarry Bay |Hubei :
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Beijing |Shanghai Sai :
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Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
Harrogate |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Renfrew | Uxbridge | Richmond Hill | North York | Mississauga | Australia |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Netanya | Tel Aviv | Yavne | Be'Er Sheva | Kfar Saba |Italy :
Italy |Lombardy :
Rho |Japan :
Japan | Saitama |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |New Zealand :
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Auckland |Lima Region :
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Warsaw |Remote :
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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 :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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