Job Title
Functional Quality Associate II (Pharmacovigilance / Safety Quality Review)
Company
Fortrea
Location
Pune, India
Employment Type
Full-time
Job Posting
Posted 12 days ago
Role Summary
This role focuses on quality review and oversight of pharmacovigilance (PV) and drug safety data, ensuring compliance with global regulatory requirements. It involves reviewing safety reports, adverse event data, and regulatory documents to maintain quality, accuracy, and compliance in clinical and post-marketing safety systems.
Key Responsibilities
Safety & Quality Review
Perform quality review of safety reports and pharmacovigilance cases
Review adverse event data from:
Clinical trials
Post-marketing surveillance
Conduct QC of safety reports for regulatory submissions such as:
IND Annual Reports
PSURs (Periodic Safety Update Reports)
PADERs (Periodic Adverse Drug Experience Reports)
Clinical Study Reports
Investigator Brochures
Protocol sections and regulatory documents
Adverse Event & Case Processing Support
Review and manage:
Expedited adverse events
Product quality complaints
Medical information queries
Ensure timely submission to clients and regulatory authorities
Support drug safety case processing, documentation, and follow-up
Assist in call intake review and case documentation
Compliance & Regulatory Support
Ensure compliance with:
ICH guidelines
GCP (Good Clinical Practice)
GVP (Good Pharmacovigilance Practices)
FDA and EU regulatory requirements
Support regulatory inspections and client audits
Contribute to audit readiness and inspection preparation
Quality Management & Process Improvement
Assist in preparation of:
CAPA (Corrective and Preventive Actions)
Quality Management Plans
Generate and analyze quality metrics and trend reports
Identify process gaps and recommend improvements
Support training programs and onboarding documentation
Participate in quality error review discussions
Stakeholder & Communication Responsibilities
Coordinate with project teams and clients
Provide quality updates and reporting metrics
Support cross-functional collaboration across safety, clinical, and regulatory teams
Respond to medical information and product-related queries
Required Qualifications
Bachelor’s / Master’s / PhD in:
Medicine
Pharmaceutical Sciences
Life Sciences / Biological Sciences
Nursing or related fields
Experience Required
Minimum 2+ years of experience in:
Pharmacovigilance (PV)
Drug safety
Safety writing or quality review in CRO/pharma/biotech industry
Experience in peer review or quality review preferred
Technical & Functional Skills
Strong knowledge of:
Medical terminology
Drug safety terminology
Understanding of:
Case processing and adverse event assessment
Global regulatory reporting requirements
Familiarity with:
GVP (Good Pharmacovigilance Practices)
ICH-GCP guidelines
FDA & EU regulations
Proficiency in MS Office tools (Excel, Word, etc.)
Preferred Skills
Experience in:
Quality metrics generation
Trend analysis
CAPA (Corrective and Preventive Action) processes
Experience assessing safety reports from:
Medical
Scientific
Documentation perspectives
Behavioral Skills
Strong analytical and problem-solving ability
Attention to detail and quality focus
Ability to identify issues and escalate appropriately
Strong communication across teams
Ability to work under timelines in regulated environments
Work Environment
Office-based role
Highly compliance-driven and regulated environment
Interaction with global safety and regulatory teams
Core Role Summary (Simple View)
This job is mainly about:
Reviewing drug safety and adverse event reports
Ensuring regulatory compliance of pharmacovigilance data
Performing quality checks on clinical and post-marketing safety documents
Supporting audits, inspections, and CAPA processes
Working in pharmacovigilance + quality systems environment
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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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Birmingham |Virginia :
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Concord | Lumberton | North Carolina |Michigan :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
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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 :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
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Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
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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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Haarlem |South Holland :
Leiden |Netherlands :
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 :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Renfrew | Mississauga | Uxbridge | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Yavne | Tel Aviv | Netanya | Be'Er Sheva | Kfar Saba |Remote :
Melbourne | Medan | Thailand | Belgium | French | Perth | Remote - Africa | Nairobi | Regulatory Labeling Manager (NA and LATAM Only) | Minnesota | Remote - Middle East | Blue Bell | Manipal | Leinster | Springville | Tulsa | Hungary | Zaragoza | Ireland | Texas | Riga | Victoria | Castlebar | Lousiana | Xzagreb | Milwaukee | Faridabad | McFarland | Switzerland | Bountiful | Slovakia | Lenexa | Remote - South America (Latin Americal) | Hammond | Green Way | Bishop | Remote - Europe |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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