Job Title: Safety Writer
Location: Mumbai, India
Category: Clinical
Job ID: 254757
The Safety Writer is responsible for preparing, reviewing, and managing aggregate safety, risk management, and signal detection documents. This role involves leading client communications for assigned reports, supporting other medical writers, conducting literature reviews, and ensuring high-quality, timely deliverables for internal and external stakeholders.
Report Writing & Review
Author and review various safety reports for global regulatory submissions, including but not limited to:
Annual Reports (IND and others)
Periodic Safety Update Reports (PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs)
Take ownership of assigned deliverables and coordinate with internal stakeholders and clients to obtain required inputs.
Perform quality review of reports prepared by junior or associate medical writers.
Author or contribute to ad hoc reports, benefit-risk evaluation reports, and justification/supporting documents for label updates.
Write Common Technical Document (CTD) summaries, including Clinical and Non-Clinical Overviews, Clinical Summaries, and other regulatory documents.
Prepare subject narratives for adverse drug reactions (ADRs) and serious adverse events (SAEs).
Literature Review & Signal Detection
Conduct scientific literature searches for authoring reports or routine surveillance activities.
Review articles selected by other writers and propose company comments.
Author literature abstracts/summaries for safety reports.
Contribute to signal reports (ad hoc and periodic) and safety issue analysis reports.
Internal & External Coordination
Participate in report planning, strategy development, kick-off meetings, and round table discussions for comment resolution.
Support creation and updating of labels, such as Core Data Sheets, USPI, centralized SPCs, and Med Guides.
Maintain effective communication with clients to ensure timely delivery of reports.
Process Compliance & Quality
Implement and promote consistent, efficient, and quality processes to meet timelines.
Ensure compliance with governing regulatory requirements, Good Pharmacovigilance Practices (GVP), and ICH/GCP guidelines.
Maintain accountability for deliverables and foster a high level of customer service.
Perform additional project-related tasks as required by management.
Minimum Requirements
First degree in Life Sciences (or equivalent; relevant experience may be considered in lieu of education).
At least 3 years of experience in the pharmaceutical industry, including a minimum of 2 years in medical writing.
Excellent command of written and spoken English.
Good knowledge of MS Office and organizational/time management skills.
Understanding of regulatory requirements, pharmacovigilance practices, and ICH/GCP guidelines.
Preferred Qualifications
Advanced degree (MSc, PhD, or equivalent) preferred.
Scientific or clinical research experience desirable.
Excellent written and verbal communication.
Strong interpersonal skills.
Ability to manage multiple tasks and meet tight deadlines.
Attention to detail and commitment to quality.
Available for occasional travel (~5%) including overnight stays as required.
Work is primarily office-based with standard physical demands.
Medical Writing
Pharmacovigilance
Safety Reporting
Signal Detection
Regulatory Submissions
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
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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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Berlin |Baden-Wurttemberg :
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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 :
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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 :
Mississauga | North York | Australia | Uxbridge | Renfrew | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |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 :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Bangkok |Israel :
Yavne | Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |Remote :
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Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
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