Full-Time
Regulatory Safety Lead
MD
ProPharma Group
1,001-5,000 employees
Regulatory sciences consultant for life sciences
No salary listed
Remote in USA
Remote
Remote within the United States; hybrid work with office days may be arranged near an office.
MD
 Legal & Compliance (1) |
|---|
Get referred to ProPharma Group
See people who can refer or advise you
- Regulatory Safety Lead (will be taking on many of the responsibilities that the current PV Head drives)
- MD required; must have previously served as Head of Pharmacovigilance / Global Drug Safety (large pharma or well‑established biotech strongly preferred)
- 15+ years of progressive experience in pharmacovigilance and regulatory safety within the biotechnology or pharmaceutical industry
- Deep, hands‑on experience representing organizations to the FDA and other global regulatory authorities, including ownership of safety interactions and inspections
- Proven leadership overseeing global PV operations, including case management, safety surveillance, risk management, benefit–risk assessment, compliance, and PV quality systems
- Demonstrated experience supporting late‑stage development and NDA/BLA submissions; this role will directly support our 2026 NDA submission
- Track record of building, scaling, and governing fit‑for‑purpose PV processes and infrastructure in preparation for commercialization
- Remote Working, Contract opportunity 6+ months in duration
ProPharma Group provides regulatory sciences consulting and related services for drugs, biologics, medical devices, and diagnostics on a global scale. Its offerings cover the full lifecycle, from early development and clinical trials to regulatory approval and post-market activities. The company’s services include regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology, delivered by a team of over 2,500 professionals with more than 20 years of operation. ProPharma Group differentiates itself by providing expert, end-to-end regulatory and life sciences solutions across multiple product types and stages, helping pharmaceutical, biotechnology, and medical device companies navigate complex regulatory and compliance challenges. The goal is to help clients bring safe and compliant products to market efficiently while maintaining ongoing lifecycle support.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Raleigh, North Carolina
Founded
2001
Get referred to ProPharma Group
See people who can refer or advise you
Simplify's Take
What believers are saying
- July 8, 2026 AI-assisted ANDA capability shortens timelines and boosts throughput.
- May 27, 2026 hiring of Adrian Pencak strengthens global sales execution.
- December 11, 2025 Hyderabad office expands delivery capacity and supports cost-efficient growth.
What critics are saying
- June 2026 trade-secret litigation against Anthony Crone exposes client-data leakage and trust damage.
- Revelio Labs shows 2,269 employees in March 2026, down 3.4% since 2023.
- AI drafting commoditizes submission work, pressuring billable hours and margins during 2026-2027.
What makes ProPharma Group unique
- ProPharma spans regulatory, clinical, quality, pharmacovigilance, and medical-information workflows end-to-end.
- July 8, 2026 AI-assisted ANDA drafting deepens its regulatory delivery moat.
- Odyssey-backed ProPharma blends consulting expertise with scalable global operations and technology enablement.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Remote Work Options
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 0%2 year growth
↑ 24%ProPharma, a global provider of regulatory, clinical, and compliance services for life sciences, has launched a proprietary AI-assisted capability to enhance Abbreviated New Drug Application submission development. The technology, part of ProPharma's Technology Enablement Strategy, aggregates and analyses information from multiple data sources to generate structured first drafts, reducing manual authoring effort. The AI tool enables ProPharma's regulatory experts to focus on scientific evaluation, strategic guidance, and quality review. According to Matthew Weinberg, president of regulatory sciences, the capability aims to reduce authoring timelines whilst maintaining scientific rigour. Chief executive Dawn Sherman emphasised that the technology enhances rather than replaces expertise. ProPharma is integrating purpose-built technologies across its service areas, including regulatory affairs, clinical research, and pharmacovigilance. The company is a portfolio company of Odyssey Investment Partners.
ProPharma advances Technology Enablement Strategy with ai-assisted capability for ANDA submission development. ProPharma's new proprietary tool accelerates regulatory submissions while ensuring top-tier quality and compliance for global pharmaceutical clients. July 8, 2026 Press Contacts Shannon Severino 412-608-2393 RALEIGH, N.C. - ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment Partners, today announced another milestone in its Technology Enablement Strategy with the deployment of a proprietary AI-assisted capability that enhances how the company develops Abbreviated New Drug Application (ANDA) submissions for clients. The AI-assisted capability was purpose-built to support ProPharma's regulatory teams and their clients in the development of ANDA submissions. By intelligently aggregating and analyzing information from multiple data sources and document formats, the technology generates structured first drafts that significantly reduce manual authoring effort. This enables ProPharma's regulatory experts to dedicate more time to scientific evaluation, strategic regulatory guidance, quality review, and client collaboration. "The future of regulatory submissions is not about replacing experts with technology," said Matthew Weinberg, President, Regulatory Sciences at ProPharma. "It's about empowering experts with better tools. By combining human expertise with AI-enabled efficiencies, we are helping clients reduce authoring timelines, improve operational effectiveness, and maintain the scientific rigor and regulatory excellence that have always been central to ProPharma's approach in a more cost-effective way." Developed specifically to enhance ProPharma's internal regulatory delivery process, the capability is designed to improve consistency, completeness, and traceability throughout submission development while supporting the rigorous quality and compliance standards expected by global health authorities. It also enables more efficient management of regulatory questions and deficiency responses throughout the submission lifecycle. For clients, these enhancements translate into meaningful benefits, including: * Accelerated ANDA preparation and submission timelines * Reduced manual document authoring effort * Improved consistency and completeness across submission content * Enhanced traceability throughout submission development * More efficient management of regulatory questions and deficiency responses * Better utilization of regulatory resources while maintaining high-quality submissions "Technology should enhance expertise, not replace it," said Dawn Sherman, Chief Executive Officer of ProPharma. "Our Technology Enablement Strategy reflects our commitment to continuously improving how we serve clients by equipping our experts with innovative capabilities that increase efficiency, strengthen quality, and accelerate delivery. This AI-assisted capability is one example of how we're investing in the future of expert-led life sciences services." Technology Enablement is ProPharma's enterprise-wide strategy for integrating proprietary technology, intelligent automation, and artificial intelligence into the way its experts deliver services across the organization. ProPharma is embedding purpose-built technologies into its expert-led delivery model across regulatory affairs, clinical research, pharmacovigilance, quality and compliance, medical information, and consulting services. The initiative is designed to improve efficiency, consistency, scalability, and client outcomes while preserving the scientific expertise, regulatory judgment, and human oversight that remain at the core of every engagement. For more than 25 years, ProPharma has improved patients' health and wellness by providing expert guidance that empowers biotech, pharmaceutical, and medical device organizations to confidently advance scientific breakthroughs and bring new therapies to market. With deep expertise in regulatory sciences, CRO services, quality and compliance, pharmacovigilance, medical information, FSP solutions, and digital transformation, ProPharma delivers integrated, end-to-end solutions that help organizations navigate complexity, mitigate risk, and accelerate the development and commercialization of life-changing therapies. For more information about ProPharma, please visit propharmagroup.com. Odyssey Investment Partners Odyssey Investment Partners is a leading private equity investment firm with more than a 25-year history of partnering with skilled managers to transform middle-market companies into more efficient and diversified businesses with strong growth profiles. Odyssey makes majority-controlled investments in industries with a long-term positive outlook and favorable secular trends. For further information about Odyssey, please visit odysseyinvestment.com.
ProPharma appoints Adrian Pencak as Chief Commercial Officer. May 27, 2026, 09:42 AM by Life Sciences Industry Veteran Appointed to Lead Global Commercial Organization RALEIGH, N.C. - May 27, 2026 - ProPharma, a leading provider of regulatory, clinical, and compliance services for the life sciences industry, today announced the appointment of Adrian Pencak as Chief Commercial Officer. He will be responsible for leading ProPharma's global commercial organization, across its full suite of regulatory, clinical, and compliance services. Pencak brings more than 25 years of executive commercial leadership experience across pharma services, clinical development, technology-enabled solutions, and global Contract Research Organizations. Throughout hiscareer, he has built and led high-performing commercial teams, driven significant global revenue growth, and developed scalable go-to-market strategies for many of the life sciences industry's leading organizations. Prior to joining ProPharma, he held senior commercial leadership positions at organizations including IQVIA, Advarra, PharmaLex, and ICON plc, where he focused on expanding strategic accounts, strengthening global partnerships, and advancing commercial growth across international markets. His experience spans both full-service outsourcing and Functional Service Provider (FSP) models, with a strong track record of supporting leading pharmaceutical, biotechnology, and life sciences organizations through complex development and commercialization initiatives. "Adrian brings deep commercial leadership experience across the life sciences services landscape and understands the importance of delivering integrated solutions that help clients navigate increasingly complex development and commercialization challenges," said Dawn Sherman, Chief Executive Officer of ProPharma. "His experience scaling global commercial organizations and building strong client partnerships will be an important asset as we continue expanding our global capabilities and supporting clients across the full product development lifecycle." "ProPharma has built an outstanding reputation for helping clients navigate complex regulatory, clinical, and compliance challenges across the product lifecycle to help bring therapies to patients faster," said Adrian Pencak. "I'm excited to join the organization at this stage of growth and look forward to partnering with teams across the business to strengthen strategic client relationships, scale commercial capabilities, and continue delivering high-value solutions that help accelerate innovation across the life sciences industry." Pencak is also active in the broader life sciences community as a speaker and contributor at industry events, including Bio-IT World and the European Clinical Data Forum. His work has included thought leadership on the use of technology and artificial intelligence in clinical and regulatory environments, as well as the modernization of pharma services operating models. About ProPharma For more than 25 years, ProPharma has improved patients' health and wellness by providing expert guidance that empowers biotech, pharmaceutical, and medical device organizations to confidently advance scientific breakthroughs and bring new therapies to market. With deep expertise in regulatory sciences, CRO services, quality and compliance, pharmacovigilance, medical information, FSP solutions, and digital transformation, ProPharma delivers integrated, end-to-end solutions that help organizations navigate complexity, mitigate risk, and accelerate the development and commercialization of life-changing therapies. For more information about ProPharma, please visit propharmagroup.com. About Odyssey Investment Partners Odyssey Investment Partners is a leading private equity investment firm with more than a 25-year history of partnering with skilled managers to transform middle-market companies into more efficient and diversified businesses with strong growth profiles. Odyssey makes majority-controlled investments in industries with a long-term positive outlook and favorable secular trends. For further information about Odyssey, please visit odysseyinvestment.com.
ProPharma, a provider of regulatory, clinical and compliance services for the life sciences industry, has appointed Adrian Pencak as Chief Commercial Officer. He will lead the company's global commercial organisation across its full service portfolio. Pencak brings over 25 years of executive commercial leadership experience in pharma services, clinical development and contract research organisations. He has previously held senior commercial positions at IQVIA, Advarra, PharmaLex and ICON plc, focusing on strategic accounts and global partnerships. In his new role, Pencak will strengthen client relationships, scale commercial capabilities and deliver solutions to accelerate innovation across the life sciences industry. He is also active in the broader life sciences community, speaking at industry events on technology and artificial intelligence in clinical environments.
ProPharma expands operations with new office in Hyderabad. Modern workspace supports continued growth and innovationRALEIGH, N.C., Dec. 11, 2025 /PRNewswire/ - ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment Partners, today announced the official inauguration of its new office in Hyderabad, India, on November 17, 2025. Strategically located in Mindspace, at the heart of Hyderabad's technology corridor (HITEC City/Madhapur), the new office places ProPharma among the world's leading Global Capability Centers (GCCs) in the pharmaceutical industry. Mindspace is also the first commercial business park in Hyderabad to receive a Gold rating from the Indian Green Building Council (IGBC). The prominent placement of the ProPharma logo atop the building underscores the company's growing presence and brand visibility in India.The expansion supports ProPharma's continued growth trajectory by providing capacity for additional team members across multiple service lines and creating a modern, collaborative environment designed to inspire innovation and connection. More than 70 employees participated in the inaugural celebration."This milestone represents an important step forward in ProPharma's global expansion," said Jason DeGoes, President, ProPharma. "Our new Hyderabad office strengthens our ability to deliver high-quality, integrated solutions for our clients around the world and reflects our commitment to building an exceptional environment for our teams.""We're proud to establish a world-class workspace in Hyderabad - one designed to foster creativity, efficiency, and collaboration," added Pavan Hemadri, Director of Business Operations, ProPharma. "This move enhances our ability to attract top local talent and better serve our clients across regulatory, clinical, and compliance domains."The new state-of-the-art facility features open, collaborative workspaces aligned with ProPharma's global culture of innovation and operational excellence. It also underscores ProPharma's long-term investment in India as a key hub supporting its worldwide operations.About ProPharmaFor the last 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. With deep domain expertise in regulatory sciences, clinical research solutions, quality and compliance, pharmacovigilance, medical information, FSP solutions, and digital transformation, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate its partners' most high-profile drug and device programs. For more information about ProPharma, please visit propharmagroup.com.About Odyssey Investment PartnersOdyssey Investment Partners is a leading private equity investment firm with more than a 25-year history of partnering with skilled managers to transform middle-market companies into more efficient and diversified businesses with strong growth profiles. Odyssey makes majority-controlled investments in industries with a long-term positive outlook and favorable secular trends. For further information about Odyssey, please visit odysseyinvestment.com.Logo - https://www.pagalparrot.com/wp-content/uploads/2025/12/ProPharma_Group_Logo.jpg View original content:https://www.prnewswire.co.uk/news-releases/propharma-expands-operations-with-new-office-in-hyderabad-302638474.html