Job Title: Safety Writer
📍 Location: Mumbai
🏢 Category: Clinical
🆔 Job ID: 255034
Job Overview
Responsible for the preparation and review of aggregate safety, risk management, and signal detection documents. The Safety Writer leads report management activities, oversees junior writers, and ensures timely delivery of high-quality documents to internal stakeholders and clients. The role involves fostering excellent client relationships while ensuring regulatory compliance and adherence to standard operating procedures.
Key Responsibilities
📄 Report Writing & Review
Write various safety reports for global regulatory submissions, including:
Annual Reports (IND and other)
Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs)
Subject narratives for adverse drug reactions (ADRs) and serious adverse events (SAEs)
Author or co-author complex or large reports.
Perform quality review of safety reports prepared by junior or associate writers.
Prepare Common Technical Document (CTD) summaries, including Non-Clinical and Clinical Overviews and Clinical Summaries.
Write ad hoc reports, benefit-risk evaluation reports, and supporting documents for label updates.
Prepare medical information responses for healthcare professionals (HCPs).
Author/contribute to signal reports and safety issue analysis reports.
🔍 Scientific Research & Literature
Conduct scientific literature searches for safety reports or routine surveillance activities.
Review literature selected by junior writers and prepare abstracts/summaries.
Propose company comments and updates to search strategies as needed.
🤝 Stakeholder Coordination
Communicate and coordinate with internal and external stakeholders to gather required inputs.
Participate in creating and updating labels (Core Data Sheets, USPI, centralized SPCs, Med Guides).
Lead report planning, strategy development, kick-off meetings, and round-table discussions for comment resolution.
⚙️ Process & Compliance
Implement and promote efficient, high-quality processes to meet timelines and deliverables.
Ensure operations are compliant with regulatory requirements and company SOPs.
Maintain a culture of high customer service.
Perform additional tasks as per project needs or manager’s discretion.
Minimum Qualifications
🎓 Education:
First degree in Life Sciences or equivalent.
Relevant experience may be considered in lieu of formal education.
💼 Experience:
At least 3 years in the pharmaceutical industry, with 2 years in medical writing preferred.
🗣️ Skills & Competencies:
Excellent command of written and spoken English
Strong organizational and time management skills
Good interpersonal and communication skills
Knowledge of MS Office
Understanding of regulatory requirements, Pharmacovigilance practices, and ICH-GCP guidelines
Scientific or clinical research experience is desirable
Preferred Qualifications
Advanced degree (e.g., PhD or Masters) in Life Sciences or related fields
Physical Demands / Work Environment
Office-based role with 5% travel, including overnight stays as needed for project requirements.
Equal Opportunity & Accommodation
Fortrea is an Equal Opportunity Employer committed to providing reasonable accommodations to qualified individuals.
📎 Learn more about EEO & Accommodations [here].
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Bhubaneswar | Rourkela |PAN-India :
Panjab :
Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Punjab :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
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Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
Tuscaloosa |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
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Wilmington |Florida :
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Hilo | Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Kington :
Frank Scottile Blvd |LA :
Baton Rouge | Monroe | New Orleans |Louisiana :
Lake Charles | Shreveport |Maine :
Bangor | Brewer |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |New Jersey :
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Albuquerque | Farmington | Santa Fe | Tucumcari |New York :
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Concord | Lumberton | North Carolina |North Caroline :
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Dickinson |northeastern :
New Hampshire |Ohio :
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Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
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Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |Carlow :
Carlow |Cork :
Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
Ballydine |Ulster :
Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
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Leiden |North Yorkshire :
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Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Uxbridge | Renfrew | Richmond Hill | Mississauga | North York | Australia |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Netanya | Yavne | Tel Aviv | Be'Er Sheva | Kfar Saba |Italy :
Italy |Lombardy :
Rho |Japan :
Saitama | Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |New Zealand :
New Zealand |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
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Manila |Mazovia :
Warsaw |Remote :
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Bucharest |Makkah :
Jeddah | Riyadh | Khulais | Najran | King Abdullah Economic City | Rabigh |Nišava District :
Niš |Singapore :
Singapore |South Africa :
South Africa | Midrand |Brazil :
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Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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Kyiv |Dubai :
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Ho Chi Minh City |