Location: Raleigh, North Carolina, United States (Remote Available)
Employment Type: Full-Time
Department: ICSR Management
Company: PrimeVigilance
Experience Required: 7–9+ years in Pharmacovigilance (including 5–7+ years in people management roles)
Eligibility: Not suitable for freshers
About the Company
PrimeVigilance, part of the Ergomed Group, is a globally established pharmacovigilance service provider delivering end-to-end safety solutions across Medical Information, Drug Safety, Regulatory Affairs, and Quality Assurance. With a strong global footprint across North America, Europe, and Asia, the organization supports pharmaceutical, biotechnology, and medical device companies across all therapeutic areas.
The Director of ICSR – Pharmacovigilance is a senior leadership role responsible for managing the ICSR Management Unit, ensuring optimal resource utilization, operational excellence, and delivery of high-quality pharmacovigilance services. This role demands deep expertise in individual case safety report (ICSR) processing, team leadership, and global safety operations.
Lead and manage the ICSR Management Unit, ensuring efficient delivery of all pharmacovigilance activities
Oversee workload distribution, productivity analysis, and resource optimization across multiple projects
Set and monitor productivity targets, ensuring high-quality case processing and compliance standards
Manage and mentor ICSR Leads and Line Managers to maintain team efficiency and performance
Collaborate with cross-functional teams including Resourcing, Quality, HR, and Commercial teams
Support project budgeting, contract development, and proposal activities
Review and approve CAPAs, quality findings, and operational improvements
Drive process optimization initiatives and implement best practices within ICSR operations
Contribute to recruitment, performance evaluation, and employee development strategies
Ensure adherence to global pharmacovigilance regulations, SOPs, and quality standards
Degree in Life Sciences, Pharmacy, Nursing, or related healthcare field
Minimum 7–9+ years of pharmacovigilance experience
At least 5–7+ years of experience in leadership or line management roles within drug safety
Strong expertise in ICSR case processing, medical review, and global safety reporting
Advanced knowledge of pharmacovigilance regulations and compliance frameworks
Excellent communication, organizational, and stakeholder management skills
Proficiency in MS Office and safety databases
Leadership and team management
Strategic resource planning and workload optimization
Analytical thinking and problem-solving
Quality and compliance focus
Cross-functional collaboration
Competitive compensation package
Remote working flexibility
Global exposure in pharmacovigilance operations
Structured training and professional development programs
Multicultural and inclusive work environment
Career growth opportunities in a fast-scaling global organization
PrimeVigilance is committed to fostering a diverse, equitable, and inclusive workplace. The organization promotes a human-centric culture where individuals from all backgrounds can thrive and contribute meaningfully.
This is a senior leadership position requiring extensive experience in pharmacovigilance and team management. Freshers and entry-level candidates should explore roles such as Drug Safety Associate, ICSR Processor, or Pharmacovigilance Associate before applying to director-level positions.
Interested candidates can apply through the official careers page. For more verified global pharmacovigilance jobs, visit ThePharmaDaily.com and stay updated with the latest opportunities in drug safety and clinical research.
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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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Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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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 :
Oklahoma City |Puerto Rico :
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Washington |Delaware :
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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 :
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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 :
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Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
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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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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Australia | Uxbridge | North York | Mississauga | Richmond Hill |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 :
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 :
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Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Sofia |Sweden :
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Warsaw |
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