Leadership

A seasoned leader in Product Management and Engineering, specializing in Life Sciences, adept at conceptualizing and crafting SaaS & AIML solutions, as well as providing consulting services tailored for Pharmaceutical, Biotech, and Medical Devices sectors. With a track record of holding leadership roles across organizations of varying sizes within Life Sciences, he possesses expertise in establishing and expanding consulting and product development practices with globally distributed teams. Notably, he has spearheaded the creation of enterprise-scale SaaS AIML applications such as automated case intake and processing, akin to IQVIA Vigilance Platform, Genpact PVAI, and Insife HALOPV, alongside analytical reporting systems. Currently at Insife, he oversees a global engineering organization spanning multiple continents, driving software development initiatives with a focus on strategic planning and seamless integration across product development, custom projects, and R&D endeavors.

With over 28 years of total experience including 16 years of working in pharmacovigilance Domain, Leena brings extensive experience to her new role as MD of Insife India. For the past 10 years, Leena played a central role in building her previous organization from scratch, which currently employs more than 500 employees. She managed all areas of the business from set up and recruitment, employee engagement and retention, finance and client relationships.

Marc has been crossing the frontier between IT and R&D in the pharmaceutical industry in Europe and the USA for more than 20 years. He supports R&D divisions to improve their business processes through the optimized use of information technology. His main fields of expertise are processes and applications for pharmacovigilance, supported by proven knowledge in international team leadership, project management, computerized systems validation and business intelligence. At Insife, Marc is leading customer implementations of HALOPV with a focus on the PSMF, Agreements and Aggregate Reports modules and leads the German Office. Marc holds a Ph.D. in physics from the University of Cologne, Germany.

Highly skilled HR professional and organizational psychologist with extensive experience in developing and executing human resource strategies, policies, and operations across international settings. Proven track record in recruitment, retention, talent management, and HR compliance. Expertise in leading diverse HR teams, and ensuring regulatory compliance in a highly regulated environment, specifically in pharmacovigilance. Excellent communication and interpersonal skills with the ability to manage sensitive conversations, support leadership, and drive company-wide HR initiatives.

Sabah Iqbal is the Global Quality Head at Insife, overseeing all quality aspects of the organization. With 15 years in the PV and life sciences domain, including over 8 years in PV and 7 in quality and compliance, she has held roles from Internal Auditor to Senior QA Manager at Insife. A certified Lead Auditor for ISO 9001:2015, Sabah is well-versed in ISO standards 9001, 27001, and 14001, GDPR, and managing audits and inspections. She holds a Master’s in Microbiology and is based in Bangalore, India.

Simon is highly experienced IT Professional, with a career of spanning over 30 years in software development. Started his career as Software Developer, moving into being a Software Consultancy, before becoming a Consultancy Practice Lead. Form there moved into Operationally lead roles such as PMO Director. He has had the privilege of building software from the “ground up” with hands on experience of design, development and delivery of a wide range of complex IT products/solutions, as well as stabilising and optimising pre-existing products/solutions. He has worked across multiple industries, with most of his time spent in Health care and life science.

Dheeraj is an experienced IT professional with over 15 years of expertise, distinguished as a leader in the life sciences domain. Specializing in developing SaaS solutions and offering pharmacovigilance consulting services, he leads as the Argus Practice Head at Insife. In this role, he manages critical Life Sciences applications on the AWS Cloud, ensuring optimal performance and scalability. Leading a team of engineers, he oversees seamless deployments and guarantees interface integration. Dheeraj's expertise encompasses application deployments, interface integration, maintenance, security, and compliance, driving innovation and continuous improvement. Previously as a PV Consultant, he focused on pharmacovigilance operations, innovative software development, implementation, Computer System Validation, and technology strategy, emphasizing regulatory compliance, business process improvements, and guidance. His focus on regulatory compliance and guidance, coupled with his dedication to business process improvements, underscores his commitment to excellence in every endeavor.

Louise is a PV subject matter expert with 15+ years of experience within Industry, consulting, PV network leadership and project management, combining deep domain knowledge with strong presentation, facilitation and problem-solving skills. She joined Insife in December 2022 with an aim to expand her horizons in the PV tech ecosystem and works with both Industry and Regulators to implement game changing technologies. Louise currently leads our Global Regulatory Intelligence Club for Pharmacovigilance (GRIP).

Andreas is a visionary and engaged Director, with innovative mindset for service development in IT for the Pharma industry; +12 years’ experience from service delivery and customers interaction for enterprise and small medium Pharma business. He has a dedicated focus delivering IT solutions optimizing business gains in Life Science.

Malin has a sound technical background, extensive experience in all facets of the software development lifecycle, paired with management, consulting and customer relationship management experience, with a strong focus on the Pharmaceutical industry. The last 15 years the focus has been on Pharmacovigilance Strategy & Systems, where she’s gained experience through various positions within the Roche / Genentech group in the Safety Risk Management area.

Ivan began as a Database Administrator before transitioning to the pharmacovigilance industry, where he specialized in GxP systems administration and project management. With over 12 years of experience, his technical competencies include expertise in Oracle database management, SQL & PLSQL programming, as well as familiarity with pharmacovigilance regulations and systems such as Argus Drug Safety System. Currently serving as Director of Service Delivery, he oversees customer operations, demonstrating excellent communication and leadership skills.

With 22 years of rich experience in IT, he has demonstrated proficiency in various facets of technology management. His expertise encompasses team leadership, budget planning, project management, and service delivery. Possessing a robust skill set, he excels in technical domains such as Microsoft platforms (Active Directory, Exchange, SharePoint, Office 365, Azure), virtualization (Microsoft Hyper-V, VMware, Oracle), cloud solutions (Azure, AWS), backup solutions (both on-premises and cloud-based), networking (Cisco, Fortinet, HP, Palo Alto), and security measures including encryption, IDS/IPS, and ethical hacking. Additionally, he holds certifications as a Microsoft Certified Trainer and ITIL v4 certified professional, alongside Microsoft and Cisco certifications. Noteworthy achievements in his career include spearheading the implementation of CRM/ERP systems from inception, deploying Identity and Access Management solutions for clients, and nurturing and leading several high-performing IT teams, facilitating successful migrations from on-premises to cloud-based environments.

Expert in Computerized Systems Validation, Process Control Systems Validation & Business Process Applications (ERP – SAP) in Pharmaceuticals, Clinical Research and Life sciences industries for regulatory compliances. He is responsible for validation and technical solutions involving laboratory Computerized System, Business Process applications, PV Systems and SaaS application implementations. He has also involved in a wide range of Validation activities and have good exposure and experience working in GxP regulatory environment. Having good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+ principles and GAMP 5 RBA. Involved in large transformation program and Migration of Infrastructure and application from one platform to another. Validation & Compliance Specialist experience in Computer System Validation, Regulatory and Compliance Management, Quality Management Systems and Pharma IT Solution Development. Managing the QMS from a validation perspective.

Tina Fumić is a seasoned marketing professional with 10 years of experience in the pharmacovigilance industry. In her role as the Sales & Marketing Manager at Insife, she has applied her deep knowledge of marketing to drive numerous successful campaigns. Tina has honed her skills across a range of marketing disciplines such as social media marketing, email marketing, and digital advertising.

Vedran is a technical solutions manager, with experience in developing IT solutions for life-science Industry, primarily focusing on various PV solutions. He has domain expertise in consulting pharma companies and other stakeholders. He is based out of Zagreb,Croatia.