Location: India (Remote Work Possible)
Company: ProductLife Group
Job Category: Pharmacovigilance / Drug Safety / Life Cycle Management
Job Type: Permanent, Full-Time
Experience Required: 1–3 years in pharmacovigilance, drug safety, or related role
ProductLife Group is a global leader in life cycle management, drug safety, and pharmacovigilance services, committed to delivering high-quality support across the pharmaceutical and healthcare industries. We provide innovative solutions for regulatory compliance, drug safety monitoring, and risk management, enabling clients to maintain product safety across global markets.
We are seeking a Case Specialist – Pharmacovigilance to join our India team. This role is responsible for managing and evaluating safety cases, ensuring data quality, regulatory compliance, and timely reporting in line with global pharmacovigilance standards. The ideal candidate will have a strong attention to detail, process-oriented mindset, and the ability to collaborate across teams in a dynamic, fast-paced environment.
Case Management & Data Quality
Perform quality control of pharmacovigilance cases.
Conduct medical evaluation of adverse event reports.
Data entry of vigilance cases into databases or client-specified formats.
Follow up with reporters via phone or email for case clarifications.
Pre-analyze complex cases prior to data entry.
Validate documentation from Data Managers, Vigilance Associates, and document specialists.
Close and archive vigilance files following standard operating procedures.
Medical Evaluation & Regulatory Compliance
Code adverse events according to applicable dictionaries.
Assess causal relationship between events and suspect products.
Determine seriousness, expected/unlisted nature, and submission requirements for each case.
Analyze inclusion/exclusion criteria for EV/MHRA cases.
Support medical information and quality complaint evaluation to identify safety concerns.
Documentation & Process Support
Develop, maintain, and implement quality documents related to pharmacovigilance activities.
Identify regulatory requirements and implement ICSR/MLM filters.
Act as key contact for specific clients under the guidance of the Line Manager.
Degree in Pharmacy (B.Pharm, M.Pharm, or Pharm.D) or equivalent.
1–3 years of experience in pharmacovigilance, drug safety, or related pharmaceutical function.
Knowledge of pharmacovigilance processes and regulatory requirements is a plus.
Experience with safety databases is preferred.
Proficiency in Microsoft Office (Word, Excel, Outlook).
Ability to manage multiple tasks, prioritize work, and meet deadlines.
Excellent communication skills in English; knowledge of French is a strong advantage.
Strong teamwork, analytical thinking, and process-oriented mindset.
Work remotely with global exposure to pharmacovigilance and drug safety operations.
Collaborate in a high-performing, inclusive, and dynamic team environment.
Opportunity to develop regulatory expertise and advance your career in global pharmacovigilance.
Access to training, mentorship, and professional development programs.
ProductLife Group is committed to providing equal employment opportunities. All employment decisions are based on qualifications, merit, and business needs, without regard to race, religion, gender, age, disability, or other legally protected characteristics. We foster an inclusive workplace and provide confidential accommodations throughout the recruitment process.
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Donegal |Meath :
Dunboyne |Dún Laoghaire :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Amsterdam |North Brabant :
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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 | Uxbridge | North York | Australia | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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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 :
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Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
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Jeddah | Riyadh | King Abdullah Economic City | Najran | Khulais | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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