Senior Pharmacovigilance Associate
Company: ICON plc
Location: Chennai, India
Department: Pharmacovigilance / Drug Safety
Job Type: Full-Time
Work Mode: Hybrid (Office With Flex)
JOB OVERVIEW
The Senior Pharmacovigilance Associate is responsible for leading pharmacovigilance and drug safety activities to ensure the ongoing safety and efficacy of pharmaceutical products. The role involves adverse event case management, safety data analysis, signal detection, periodic safety reporting, risk management, regulatory compliance, database oversight, and collaboration with cross-functional teams to maintain global pharmacovigilance standards.
KEY RESPONSIBILITIES
Pharmacovigilance & Case Management
Lead the collection, evaluation, and processing of adverse event reports.
Ensure timely and accurate case processing in accordance with global regulatory requirements.
Review and validate Individual Case Safety Reports (ICSRs).
Ensure compliance with company SOPs and pharmacovigilance procedures.
Monitor case quality, completeness, and submission timelines.
Safety Data Analysis
Analyze pharmacovigilance data to identify safety trends and emerging safety signals.
Perform signal detection and benefit-risk assessments.
Interpret complex safety data to support medical decision-making.
Escalate potential safety concerns for further investigation.
Support ongoing pharmacovigilance surveillance activities.
Regulatory Reporting
Prepare and submit Periodic Safety Update Reports (PSURs).
Support preparation of aggregate safety reports and regulatory submissions.
Ensure compliance with international pharmacovigilance regulations.
Maintain complete regulatory documentation.
Support health authority reporting requirements.
Risk Management
Collaborate with Medical Affairs and Clinical teams on safety evaluations.
Contribute to risk management plans and pharmacovigilance activities.
Assess clinical relevance of adverse event reports.
Support benefit-risk assessments for marketed and investigational products.
Participate in safety review meetings.
Database Management
Maintain pharmacovigilance databases and safety records.
Ensure data integrity, quality, and regulatory compliance.
Review database entries for accuracy and completeness.
Support database reconciliation activities.
Maintain audit-ready documentation.
Training & Quality Support
Train and mentor junior pharmacovigilance associates.
Provide guidance on pharmacovigilance regulations and best practices.
Support internal audits and regulatory inspections.
Participate in quality improvement initiatives.
Ensure compliance with SOPs, GVP, and company quality standards.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Pharmacy (B.Pharm)
Life Sciences
Nursing
Biotechnology
Biomedical Sciences
Medicine
Healthcare
Or a related scientific discipline
Preferred
Master's Degree in Pharmacy, Life Sciences, Clinical Research, or a related healthcare discipline.
EXPERIENCE REQUIREMENTS
Required
Extensive experience in Pharmacovigilance or Drug Safety.
Strong experience with adverse event case processing and safety surveillance.
Knowledge of global pharmacovigilance regulations and industry standards.
Experience with pharmacovigilance databases and safety systems.
Preferred
Experience in signal detection and aggregate safety reporting.
Experience preparing PSURs and regulatory safety documents.
Experience supporting regulatory inspections and audits.
Experience mentoring junior team members.
Experience in global clinical trials or post-marketing pharmacovigilance.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Remote, India | Siliguri |Illinois :
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Bavaria |Bavaria :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Cork | Dublin | Limerick | Waterford |Ulster :
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
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Brussels |Antwerp :
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Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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