Senior / Lead Medical Reviewer | Pharmacovigilance & Safety Writing | Bangalore
Company: Not Disclosed
Location: Bangalore, India
Job Type: Full-Time
Work Mode: On-site / Hybrid (as per company policy)
Experience: 1–3+ Years (Aggregate Reporting / PV Experience)
Category: Pharmacovigilance / Drug Safety / Medical Review
Job Overview
We are looking for a Senior / Lead Medical Reviewer specializing in pharmacovigilance, aggregate safety reporting, and risk management.
This role focuses on reviewing and authoring high-quality safety documents such as PSUR, DSUR, RMP, PBRER, and PADER, ensuring compliance with GVP, ICH, and global regulatory guidelines.
You will lead safety review activities, mentor junior team members, and collaborate with cross-functional teams to ensure timely delivery of compliant safety reports, contributing directly to patient safety and regulatory success.
Key Responsibilities
Safety Writing & Medical Review
Review and author aggregate safety reports (PSUR, DSUR, PBRER, PADER, RMP)
Ensure medical accuracy, consistency, and regulatory compliance
Provide expertise for finalization of risk management and safety documents
Pharmacovigilance & Signal Management
Support signal detection and risk evaluation activities
Ensure adherence to GVP, ICH, USFDA, and global PV regulations
Assist in patient safety monitoring and regulatory reporting
Project & Team Management
Manage timelines, deliverables, and logistics for safety report development
Act as point of contact for clients and internal PV teams
Conduct daily status meetings and project tracking activities
Training & Mentorship
Mentor and train junior team members in aggregate reporting and PV processes
Ensure team compliance with SOPs, training requirements, and quality standards
Drive continuous improvement in team performance
Audit & Compliance Support
Participate in internal audits, client audits, and regulatory inspections
Ensure all trackers, documentation, and SOPs are up to date
Support development and updates of SOPs and working instructions (WIs)
Cross-Functional Collaboration
Work with case processing (ICSR), literature review, and safety teams
Coordinate with stakeholders to ensure quality and timely report delivery
Provide inputs to client-specific guidance and regulatory documentation
Required Skills & Qualifications
Education
Graduate/Postgraduate in Life Sciences, Pharmacy, Medicine, Dentistry, or Allied Health Sciences
Experience
1–3+ years of experience in:
Aggregate reporting
Signal management
Risk Management Plans (RMP)
Technical Skills
Strong knowledge of:
Pharmacovigilance (PV) and drug safety processes
GVP, ICH, USFDA guidelines
Aggregate reports: PSUR, DSUR, PBRER, PADER
Familiarity with ICSR, literature review, and safety databases
Core Competencies
Excellent scientific writing and medical review skills
Strong attention to detail and analytical thinking
Effective communication and stakeholder management
Ability to manage multiple projects and timelines
Leadership and mentoring capabilities
Preferred Skills
Experience in global pharmacovigilance projects
Exposure to regulatory inspections and audits
Knowledge of signal detection tools and safety databases (e.g., Argus, ArisG)
Familiarity with risk minimization and benefit-risk evaluation
Perks & Benefits
Opportunity to work in global pharmacovigilance and drug safety projects
Exposure to regulatory submissions and aggregate safety reporting
Career growth in drug safety, risk management, and medical review
Collaborative and learning-focused work environment
High-impact role contributing to patient safety and compliance
Compensation
Salary Range: Not disclosed (competitive as per PV industry standards)
About the Company
A leading pharmacovigilance and clinical research organization specializing in drug safety, aggregate reporting, and regulatory compliance, supporting global pharmaceutical companies in ensuring patient safety and regulatory excellence.
Call to Action
If you want to build expertise in pharmacovigilance, safety writing, and global regulatory reporting, this role is for you.
Take the next step in your career and become a key contributor in drug safety and risk management.
👉 Apply now and shape the future of patient safety in pharma! 🚀
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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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 :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Birmingham |Virginia :
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Boulder | Denver | Westminster |Connecticut :
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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 :
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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 :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
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Wilmington |North Rhine Westphalia :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Hamburg |Rhineland Palatinate :
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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 :
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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 :
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Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
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Haarlem |South Holland :
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 | Uxbridge | Renfrew | North York | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |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 :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Jakarta |East Java :
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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 :
Kfar Saba | Tel Aviv | Netanya | Be'Er Sheva | Yavne |Remote :
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Cairo |Mexico :
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Kyiv |Lima Region :
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Niš |Bohemia :
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Santiago |Bosnia and Herzegovina :
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Sofia |Sweden :
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Warsaw |
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