Company Overview
ProPharma Group has spent over 20 years improving patient health and wellness by supporting biotech, medical device, and pharmaceutical organizations. Through its advise–build–operate model, ProPharma delivers end-to-end solutions across the full product lifecycle.
With expertise in:
Regulatory Sciences
Clinical Research Solutions
Quality & Compliance
Pharmacovigilance
Medical Information
R&D Technology
ProPharma helps partners de-risk and accelerate high-impact drug and device programs.
Role Title
Pharmacovigilance (PV) Safety Scientist – Benefit-Risk Team
Role Summary
We are seeking a detail-oriented and dedicated PV Safety Scientist to support pharmacovigilance activities and ensure the timely delivery of high-quality safety and regulatory outputs.
You will collaborate with senior PV scientists, management, and cross-functional stakeholders to produce accurate, compliant safety documentation.
Work Mode: Remote
Location Preference: Candidates based in or near Hyderabad (periodic office visits expected)
Key Responsibilities
Aggregate Safety Reporting
Author:
PSURs / PBRERs
PADERs / Annual Reports / ACO
DSURs
Risk Management
Prepare and maintain Risk Management Plans (RMPs)
Signal Management
Author and contribute to signal management reports
Literature & Data Review
Conduct literature searches, screening, and validity checks
Perform duplicate checks using appropriate tools
Extract and validate safety data (e.g., RSI, sales data, signals)
Data Handling & Reporting
Generate and review line listings (LLs)
Maintain and reconcile process trackers
Compliance & Quality
Ensure all deliverables meet global regulatory standards and timelines
Support audits and inspections as a Subject Matter Expert (SME)
Contribute to:
SOPs / Work Instructions
Deviations and CAPAs
Additional Support
Assist with high-priority and ad hoc pharmacovigilance activities
Skills & Competencies
Strong analytical and problem-solving skills
High attention to detail and quality focus
Effective time management and organization
Ability to work in a global, matrix environment
Strong medical writing and communication skills
Ability to interpret and summarize complex scientific data
Knowledge of global PV regulations (ICH-GCP, FDA, EMA)
Proficiency in:
MS Word, Excel, PowerPoint
Web-based applications
Education Requirements
Bachelor’s or Master’s degree in:
Pharmacy
Nursing
Life Sciences
Related scientific/healthcare field
Equivalent experience may be considered
Experience Requirements
Minimum 2+ years in Pharmacovigilance
Experience in one or more areas:
Aggregate safety report writing
Literature search and screening
Signal detection
Additional desirable experience:
Authoring/reviewing aggregate reports
Exposure to quality metrics
Client-facing interactions
Work Culture & Values
Commitment to Diversity, Equity & Inclusion
Encourages authenticity, collaboration, and innovation
Equal Opportunity Employer
Provides a supportive and empowering workplace
Additional Information
All applications are personally reviewed by the recruitment team
No AI-based screening is used
Every applicant will receive a response
Hybrid work is encouraged for employees near office locations
Important Notice
ProPharma Group does not accept unsolicited resumes from recruiters or third parties
No phone calls or emails regarding this role
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Remote, India | Siliguri |Illinois :
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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 :
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Frank Scottile Blvd |Missouri :
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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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Washington |Delaware :
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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 :
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 :
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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 :
Uxbridge | Australia | North York | Renfrew | Mississauga | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |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 :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Kfar Saba | Tel Aviv | Yavne | Be'Er Sheva | Netanya |Remote :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Rabigh | Khulais | King Abdullah Economic City | Najran | Riyadh | 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 :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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