Patient Safety Associate I – Parexel (Hyderabad, India)
Experience Required: 0–2 years (Fresher-Friendly Role)
Employment Type: Full-Time
Application Deadline: November 20, 2025
Job ID: R0000035109
Parexel is hiring a fresher-friendly Patient Safety Associate I to support global drug safety, ICSR processing, and medical monitoring activities across clinical trials and post-marketing surveillance. This role is ideal for fresh graduates or early-career professionals seeking to begin their journey in pharmacovigilance within a global CRO.
Role Overview
The Patient Safety Associate I ensures accurate processing of Individual Case Safety Reports (ICSRs), regulatory compliance, and safety data quality. This entry-level position offers structured training, exposure to global PV workflows, and a strong foundation for a long-term pharmacovigilance career.
Key Responsibilities
ICSR Processing & Safety Operations
Process ICSRs from multiple clinical and post-marketing sources.
Conduct triage for completeness and regulatory validity.
Perform data entry, coding, and follow-up activities in safety databases.
Draft high-quality patient case narratives.
Maintain safety files, project documentation, and reporting logs.
Regulatory Reporting & Compliance
Support global and local regulatory submissions.
Assist with expedited reporting procedures and SUSAR unblinding.
Perform literature searches to support signal detection and safety surveillance.
Participate in quality control, metrics tracking, and compliance monitoring.
Prepare documentation for audits and inspections.
Project & Clinical Support
Assist in the creation of study-specific safety workflows, templates, and SOPs.
Support UAT during safety database setup.
Collaborate with Safety Physicians and Medical Directors during medical monitoring activities.
Attend investigator meetings and internal training.
Facilitate submissions via systems such as ISIS (International Safety Information System).
Skills & Core Competencies
Strong analytical and problem-solving skills
Ability to conduct structured database and literature searches
Clear written and verbal communication
Strong prioritization and organization abilities
Team-driven and client-focused mindset
Comfort using safety databases and standard software tools
Preferred Experience
Fresher applicants accepted
Any internship, training, or basic exposure to pharmacovigilance, drug safety, medical coding, or clinical research is an advantage
Educational Qualifications
Postgraduate in Pharmacy, Pharmacovigilance & Clinical Research
or
Bachelor of Dentistry (BDS)
or
Life science degree with fundamental understanding of drug safety operations
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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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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Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
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 :
Ballina | Sydney |Republic of Western Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
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Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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Bangkok |Israel :
Netanya | Kfar Saba | Yavne | Tel Aviv | Be'Er Sheva |Remote :
McFarland | Green Way | Springville | Nairobi | Remote - South America (Latin Americal) | French | Melbourne | Remote, USA | Zaragoza | Medan | Lenexa | Switzerland | Remote - Africa | Bountiful | Remote | Castlebar | Leinster | Bishop | Lousiana | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Texas | Riga | Faridabad | Remote - Europe | Belgium | Tulsa | Minnesota | Ireland | Remote - Middle East | Hammond | Manipal | Slovakia | Victoria | Blue Bell | Xzagreb |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
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Rabigh | Jeddah | King Abdullah Economic City | Khulais | Najran | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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