MedDRA Specialist | Senior Process Compliance Review & Analysis
Location: Pune
Work Model: Hybrid
Employment Type: Full Time
Job Overview
The MedDRA Specialist | Senior Process Compliance Review & Analysis is responsible for delivering high-quality pharmacovigilance and quality review services to internal and external clients while ensuring compliance with global regulatory requirements, company procedures, and quality standards. The role focuses on quality review, process compliance, safety data management, CAPA management, trend analysis, and continuous process improvement within Pharmacovigilance operations.
MedDRA Certification is preferred for this position.
Summary of Responsibilities
Take ownership of assigned quality review activities across projects.
Compile quality metrics and identify trends to support continuous improvement initiatives.
Assist in addressing periodic client quality reviews and ad-hoc quality findings.
Prepare initial drafts of Corrective and Preventive Action (CAPA) plans.
Review safety cases, regulatory submissions, labeling documents, and pharmacovigilance deliverables, including:
Annual Reports
IND Reports
PSURs
PADERs
Clinical Study Reports (CSRs)
Core Data Sheets
USPI
SPCs
Medication Guides
Support quality operations related to adverse event management across clinical trials and post-marketing activities.
Review and manage expedited adverse events, product quality complaints, and medical information cases.
Ensure submissions to clients and regulatory authorities are completed within required timelines.
Manage assigned CAPAs and ensure timely closure with appropriate documentation.
Participate in process reviews and contribute to process improvement initiatives.
Develop and maintain training schedules and training materials for new and existing team members.
Lead discussions on quality findings and identify opportunities for operational excellence.
Share best practices across projects and teams.
Support client audits, regulatory inspections, and external audits.
Draft quality management plan sections for assigned projects.
Support clients during regulatory inspections with guidance from Quality Leads and Managers.
Promote standardized, efficient, and compliant operational processes.
Review and respond to:
Medical information inquiries
Product quality complaints
General pharmacovigilance-related queries
Review information received through phone calls, emails, and other communication channels.
Execute drug safety data management activities, including:
Call intake review
Case documentation review
Case follow-up activities
Guide and support Safety Associates in handling voice calls when required.
Perform quality control reviews, reconciliation activities, and metric tracking.
Analyze operational and quality data to identify process improvement opportunities.
Review analyses performed by others and drive excellence initiatives.
Perform additional duties as assigned.
Qualifications (Minimum Required)
Bachelor's, Master's, or PhD degree in:
Medicine
Alternative Medicine
Medical Sciences
Pharmaceutical Sciences
Nursing
Life Sciences
Related Healthcare Disciplines
Equivalent experience may be considered in lieu of formal qualifications.
Experience (Minimum Required)
Minimum 4 years of experience within:
Pharmaceutical Industry
Biotechnology Industry
CRO Industry
Primary experience in:
Pharmacovigilance
Drug Safety
Safety Writing
Minimum 1 year of experience in:
Peer Review
Quality Review
Compliance Review
Strong knowledge of:
Good Pharmacovigilance Practices (GVP)
FDA Regulations
EU Pharmacovigilance Guidelines
Drug Safety Regulations
In-depth understanding of:
Case Processing
Medical Assessment
Safety Data Review
Pharmacovigilance Quality Processes
Knowledge of Quality Assurance methodologies.
Awareness of Lean and Continuous Improvement concepts.
Proficiency in Microsoft Office applications.
Strong analytical, documentation, and communication skills.
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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Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tamil nadu | Tiruchirappalli | tiruppur | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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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 :
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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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Birmingham |Virginia :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
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 :
Lebanon | Macon | Manchester |Portugal :
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 :
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 :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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 :
Australia | Renfrew | Richmond Hill | Uxbridge | Mississauga | 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 :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Tel Aviv | Be'Er Sheva | Kfar Saba | Netanya | Yavne |Remote :
Switzerland | Faridabad | Texas | Manipal | Remote - Europe | Riga | Hungary | French | Thailand | Zaragoza | Leinster | Green Way | Belgium | Perth | Tulsa | Melbourne | Milwaukee | Castlebar | Remote - Africa | Victoria | Bountiful | Minnesota | Blue Bell | Slovakia | Hammond | McFarland | Bishop | Ireland | Xzagreb | Lousiana | Springville | Nairobi | Regulatory Labeling Manager (NA and LATAM Only) | Remote - South America (Latin Americal) | Remote - Middle East | Lenexa | Medan |Republic of Colombia :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
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Riyadh | King Abdullah Economic City | Najran | Jeddah | Khulais | Rabigh |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
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