Job Title: Safety Writing Assistant II
Location: Mumbai
Category: Clinical
Job ID: 251688
Job Overview:
Assist in the preparation and review of parts of aggregate safety, risk management, and signal detection reports. Contribute to data collection, content development, and review activities to support timely and high-quality document delivery for global regulatory submissions.
Summary of Responsibilities:
Generate reports/outputs from databases or safety systems, manage data requests, perform sales data calculations, and regulatory website searches.
Collate report planning materials and support the development of global safety reports: IND Annual Reports, PSURs, PADERs, PBRERs, DSURs, RMPs.
Author assigned sections of safety reports using templates or pre-existing content. Conduct safety analyses of low to medium complexity.
Annotate line listings, prepare case narratives or data summaries, and contribute to comment resolution meetings.
Assist with signal detection: clean/review data, annotate line listings, prepare signal review materials and parts of signal reports.
Support preparation of ad hoc safety documents (e.g., safety issue analysis reports, label justification documents).
Draft sections of CTD Summaries (Non-Clinical and Clinical Overviews, Clinical Summaries).
Conduct and review literature searches. Select and summarize relevant articles for inclusion in safety reports.
Adhere to standard operating procedures and regulatory guidelines to ensure consistency and compliance.
Maintain high standards of service and assume responsibility for assigned deliverables.
Perform other project tasks as needed upon training completion.
Qualifications (Minimum Required):
Bachelor’s degree in life sciences or equivalent.
Minimum 6 months to 1 year of experience in the pharmaceutical industry.
Strong command of English with solid written and verbal communication skills.
Proficient in MS Office and strong organizational/time management abilities.
Interpersonal and teamwork skills.
Understanding of pharmacovigilance practices, ICH GCP guidelines, and regulatory requirements.
Preferred Qualifications:
Master’s degree or PhD in life sciences or pharmacy.
Experience in scientific or clinical research.
Work Environment:
Available for up to 5% travel, including occasional overnight stays depending on project and office requirements.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
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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) :
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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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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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 :
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Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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Tuscaloosa |D.C :
Washington |Delaware :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
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Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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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 :
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 :
Seoul |Kazakhstan :
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Bangkok |Israel :
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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 :
Cairo |Mexico :
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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