Senior Pharmacovigilance Reporting Associate
Location: Chennai, India
Work Model: Hybrid (Office with Flexibility)
Employment Type: Full-Time
Company: ICON plc
Job Summary
The Senior Pharmacovigilance Reporting Associate is responsible for the preparation, review, submission, and compliance management of safety reports and pharmacovigilance documentation in accordance with global regulatory requirements. The role ensures accurate and timely reporting of adverse events, aggregate safety reports, and regulatory submissions while maintaining high standards of data quality and regulatory compliance.
The incumbent will collaborate with Pharmacovigilance, Clinical Operations, Regulatory Affairs, Medical Review, and Quality teams to support global drug safety activities and ensure patient safety throughout the product lifecycle.
Key Responsibilities
Safety Reporting & Regulatory Submissions
Prepare, review, and submit safety reports in compliance with global regulatory requirements and company procedures.
Ensure timely submission of:
Individual Case Safety Reports (ICSRs)
Serious Adverse Event (SAE) Reports
SUSAR Reports
Expedited Safety Reports
Regulatory Safety Notifications
Monitor submission timelines and ensure compliance with reporting obligations.
Coordinate with regulatory authorities, sponsors, and internal stakeholders regarding safety submissions.
Pharmacovigilance Case Management Support
Review and assess safety data received from clinical trials, post-marketing surveillance, literature, and spontaneous reports.
Ensure completeness, consistency, and accuracy of safety case information.
Support case processing teams in resolving data discrepancies and follow-up requirements.
Verify quality and integrity of pharmacovigilance data prior to submission.
Aggregate Safety Reporting
Assist in preparation and review of aggregate safety reports, including:
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Development Safety Update Reports (DSURs)
Annual Safety Reports
Line Listings and Summary Tabulations
Support compilation and analysis of safety information for regulatory reporting.
Signal Detection & Safety Analysis
Collaborate with safety physicians and regulatory teams to review emerging safety data.
Analyze safety trends and identify potential safety signals.
Escalate safety concerns and contribute to risk assessment activities.
Support benefit-risk evaluations and safety monitoring activities.
Pharmacovigilance Database Management
Maintain and update safety databases accurately and efficiently.
Ensure data quality through:
Data validation
Reconciliation activities
Quality checks
Regulatory compliance reviews
Support database maintenance and audit readiness activities.
Compliance & Inspection Readiness
Ensure adherence to:
ICH Guidelines
GVP (Good Pharmacovigilance Practices)
FDA Regulations
EMA Requirements
Local Regulatory Requirements
Company SOPs
Participate in internal audits, sponsor audits, and regulatory inspections.
Assist in preparation of inspection-related documentation.
Support CAPA implementation arising from audits and inspections.
Cross-Functional Collaboration
Work closely with:
Pharmacovigilance Teams
Drug Safety Physicians
Clinical Operations
Regulatory Affairs
Medical Writing
Quality Assurance
Data Management Teams
Sponsors and Regulatory Authorities
Provide safety reporting expertise across projects and programs.
Support resolution of safety reporting issues and compliance concerns.
Training & Mentorship
Provide guidance and training to junior pharmacovigilance associates.
Support onboarding and development of team members.
Share knowledge of regulatory requirements and safety reporting processes.
Contribute to continuous improvement initiatives and best practice implementation.
Educational Qualifications
Required
Bachelor’s Degree in:
Pharmacy (B.Pharm)
Life Sciences
Biotechnology
Nursing
Medicine
Biological Sciences
Healthcare Sciences
Related Scientific Discipline
Preferred
Master’s Degree in Pharmacy, Life Sciences, Public Health, or related field.
Experience Requirements
Required
Minimum 5+ years of Pharmacovigilance experience.
Strong experience in:
Regulatory Safety Reporting
Safety Submissions
Adverse Event Reporting
Pharmacovigilance Operations
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 | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Birmingham |Virginia :
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Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
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