Senior Safety Medical Writer
Department: Safety Medical Writing, Safety Surveillance, Global Patient Safety
Function: Regulatory Affairs & Pharmacovigilance
Location: Bangalore, Karnataka, India
Employment Type: Full-Time
Experience Required: 7+ Years
Industry: Pharmaceutical / Biotechnology / Drug Safety / Pharmacovigilance
Position Overview
We are seeking an experienced and highly skilled Senior Safety Medical Writer to support global pharmacovigilance and patient safety activities through the preparation of complex regulatory safety documents and aggregate safety reports.
The Senior Safety Medical Writer will serve as a subject matter expert in pharmacovigilance documentation, leading high-complexity writing assignments while ensuring scientific accuracy, regulatory compliance, and timely delivery of critical safety reports. This role requires extensive expertise in aggregate safety analyses, risk management planning, regulatory guidelines, and cross-functional collaboration.
The successful candidate will contribute significantly to patient safety by ensuring clear, concise, and scientifically robust communication of product safety information throughout the product lifecycle.
Key Responsibilities
Aggregate Safety Reporting
Lead the preparation, authoring, and review of complex aggregate safety reports.
Develop scientifically accurate and regulatory-compliant safety documentation.
Analyze and summarize safety data from multiple sources to support benefit-risk evaluation.
Ensure consistency, quality, and compliance across all safety deliverables.
Key Documents Include:
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs)
Aggregate Safety Assessment Reports
Health Authority Response Documents
Safety Narratives and Supporting Documentation
Risk Management & Safety Evaluation
Contribute to the development and maintenance of product Risk Management Plans.
Support benefit-risk assessments throughout product development and commercialization.
Collaborate with safety physicians and surveillance teams to evaluate emerging safety information.
Translate complex safety analyses into clear regulatory documentation.
Regulatory Documentation & Health Authority Support
Prepare responses to regulatory authority inquiries regarding safety-related matters.
Support global regulatory submissions by providing high-quality safety documentation.
Ensure compliance with international pharmacovigilance regulations and reporting standards.
Participate in preparation of submission-ready safety documents for regulatory agencies worldwide.
Cross-Functional Collaboration
Collaborate with:
Safety Physicians
Pharmacovigilance Scientists
Regulatory Affairs Teams
Clinical Development Teams
Epidemiologists
Biostatisticians
Medical Affairs Professionals
Provide scientific writing expertise during document planning and development.
Facilitate alignment across stakeholders regarding document strategy, content, and messaging.
Lead discussions to resolve complex scientific and regulatory issues.
Compliance & Regulatory Intelligence
Monitor updates to global pharmacovigilance regulations, guidance documents, and industry standards.
Evaluate the impact of regulatory changes on safety documentation processes.
Support implementation of new regulatory requirements and internal procedures.
Ensure all deliverables meet global compliance expectations.
Innovation & Digital Transformation
Contribute to innovation initiatives within Safety Medical Writing.
Support implementation of:
Artificial Intelligence (AI)-enabled authoring solutions
Structured Authoring Technologies
Automation Tools
Digital Documentation Platforms
Identify opportunities to improve efficiency, quality, and scalability of safety reporting processes.
Process Improvement & Knowledge Sharing
Drive continuous improvement initiatives across the Safety Medical Writing function.
Develop best practices and standardized approaches for document preparation.
Mentor junior and mid-level medical writers.
Provide training and guidance on scientific writing, safety reporting, and regulatory requirements.
Promote knowledge sharing across global teams.
Required Qualifications
Education
Mandatory
Master’s Degree and/or PhD in one of the following disciplines:
Pharmacy
Medicine
Pharmacology
Life Sciences
Veterinary Sciences
Biological Sciences
Biotechnology
Related Scientific Disciplines
Experience Requirements
Mandatory Experience
Minimum 7+ years of experience in:
Pharmacovigilance
Drug Safety
Safety Medical Writing
Regulatory Writing
Extensive experience authoring aggregate safety reports and pharmacovigilance documentation.
Strong understanding of global drug development and patient safety processes.
Preferred Experience
Experience supporting Marketing Authorization Applications (MAA).
Experience with New Drug Applications (NDA), Biologics License Applications (BLA), or similar regulatory submissions.
Experience working in global pharmaceutical, biotechnology, or CRO environments.
Experience implementing AI or structured authoring solutions within medical writing workflows.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Birmingham |Virginia :
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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 :
Knoxville | Memphis | Nashville |Louisiana :
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 :
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Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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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 :
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 :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 :
Richmond Hill | Renfrew | Mississauga | Uxbridge | Australia | 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 :
Japan | Saitama |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 :
Yavne | Tel Aviv | Netanya | Be'Er Sheva | Kfar Saba |Remote :
Melbourne | Medan | Thailand | Belgium | French | Perth | Remote - Africa | Nairobi | Regulatory Labeling Manager (NA and LATAM Only) | Minnesota | Remote - Middle East | Blue Bell | Manipal | Leinster | Springville | Tulsa | Hungary | Zaragoza | Ireland | Texas | Riga | Victoria | Castlebar | Lousiana | Xzagreb | Milwaukee | Faridabad | McFarland | Switzerland | Bountiful | Slovakia | Lenexa | Remote - South America (Latin Americal) | Hammond | Green Way | Bishop | Remote - Europe |Republic of Colombia :
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Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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