Job Title: Safety Writer
Location: Mumbai
Category: Clinical
Job ID: 251686
Job Overview:
Responsible for preparing and reviewing safety, risk management, and signal detection documents. Manages safety report deliverables, leads client communications, supports junior writers, and ensures the timely delivery of high-quality documents aligned with regulatory expectations.
Summary of Responsibilities:
Lead planning activities, data collection, kick-off meetings, and roundtable comment resolution discussions.
Write or co-author global regulatory safety reports: Annual Reports (IND and others), PSURs, PADERs, DSURs, RMPs.
Perform quality reviews of safety reports authored by peers or junior writers.
Contribute to ad hoc reports, benefit-risk evaluation reports, and labeling support documents.
Write CTD Summaries (Non-Clinical and Clinical Overviews, Clinical Summaries).
Prepare medical information responses for healthcare professionals.
Author/contribute to signal reports (periodic/ad hoc) and safety issue analysis reports.
Write narratives for adverse drug reactions and serious adverse events.
Communicate with internal teams and external clients to gather necessary report inputs.
Create and revise labeling documents: Core Data Sheets, USPI, SPCs, Med Guides.
Conduct and review literature searches for reports and surveillance; suggest updates to search strategies.
Write literature abstracts/summaries and propose company comments.
Promote consistency, quality, and efficiency in safety writing processes.
Ensure compliance with regulatory requirements and SOPs.
Maintain a high standard of customer service and accountability.
Perform additional tasks as required by project or manager, post training.
Qualifications (Minimum Required):
Bachelor’s degree in life sciences or a related field (or equivalent experience).
Demonstrated writing experience in clinical/safety domains.
Strong command of written English and scientific communication.
Familiarity with regulatory safety writing practices and pharmacovigilance guidelines.
Preferred Qualifications:
Advanced degree (e.g., Master’s or PhD) in life sciences or pharmacy.
Experience with CTD documentation and global safety reporting standards.
Work Environment:
Office-based or remote setting depending on project requirements.
Collaborative, client-focused work culture with performance accountability.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
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Baddi | Solan |Rajasthan :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
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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Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
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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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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
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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 :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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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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 :
North York | Australia | Uxbridge | Renfrew | Richmond Hill | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |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 :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |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) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Bountiful | Slovakia | Texas | Remote - South America (Latin Americal) | Xzagreb | Remote - Europe | Leinster | Nairobi | Hungary | Springville | Riga | Blue Bell | Regulatory Labeling Manager (NA and LATAM Only) | Switzerland | Remote - Middle East | Faridabad | Melbourne | Remote - Africa | Castlebar | Green Way | Lenexa | Zaragoza | McFarland | Medan | Tulsa | Manipal | Lousiana | Hammond | Remote | Minnesota | Belgium | Thailand | Victoria | French | Remote, USA | Bishop | Ireland |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Jeddah | Najran | Rabigh | Khulais | King Abdullah Economic City | 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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