• This role will focus on the outward-facing integration layer—ensuring that mainframe data and services can be effectively consumed by digital channels, analytics platforms, data lakes, technologies, and modern applications. • Own the services that expose mainframe transactions and data as modern, consumable APIs for digital use cases, working closely with product and engineering teams to package and deliver mainframe services to external clients using API enablement. • Define and communicate a clear product vision for our mainframe hybrid data & integration services portfolio. • Craft compelling value propositions that resonate with both technical buyers and business stakeholders. • Drive the commercial success of your product portfolio, including pricing strategy, packaging, sales enablement, and go-to-market planning. • Own the product roadmap for your portfolio, making prioritization decisions based on customer value, strategic alignment, and commercial impact. • Develop deep understanding of customer needs, pain points, and buying behaviors related to mainframe data accessibility and integration challenges. • Work cross-functionally with engineering, architecture, sales, marketing, finance, and customer success teams.

• Design and implement advanced ML models and statistical methods to optimize forecasting, risk assessment, and decision-making processes. • Conduct data provenance tracking, ensuring documentation of sources, transformations, and lineage for compliance with governance policies. • Submit the Data Provenance & Lineage Report, summarizing transformation workflows, feature engineering processes, and audit compliance. • Implement sprint-based Agile methodologies, ensuring rapid development cycles, backlog grooming, and alignment with mission requirements. • Provide a Rough Order of Magnitude (ROM) Estimate Report before each analytics project, detailing expected Full-Time Equivalent (FTE) hours, compute costs, storage consumption, and infrastructure requirements. • Conduct quarterly reviews to track cost efficiency, assess system performance, and optimize analytic workflows through the Quarterly Cost & Resource Utilization Report.

• Develop and refine predictive models. • Conduct exploratory data analysis. • Generate AI-driven insights to enhance intelligence and operational planning. • Integrate customer feedback into model iteration cycles, leveraging Agile development methodologies. • Submit Predictive Model Performance Report, documenting key findings, model accuracy metrics, and operational impact assessments. • Implement sprint-based Agile methodologies, ensuring rapid development cycles, backlog grooming, and alignment with mission requirements. • Conduct quarterly reviews to track cost efficiency, assess system performance, and optimize analytic workflows through the Quarterly Cost & Resource Utilization Report.

Role Description The Pharmacovigilance Signal Detection Lead is a senior expert responsible for leading and executing signal detection and evaluation activities across assigned client portfolios. The role combines scientific and epidemiological expertise with operational oversight of signal management workflows, ensuring that emerging safety signals are identified, assessed, prioritized, and communicated in compliance with applicable regulatory requirements (EMA GVP Module IX, ICH E2E, FDA) and client-specific procedures. The Signal Management Lead serves as the subject matter expert for signal-related activities and collaborates closely with medical reviewers, project leads, and client stakeholders. Essential Functions - Lead the design, execution, and oversight of signal detection activities, including quantitative analyses (PRR, ROR, EBGM) applied to spontaneous reporting databases (FAERS, EudraVigilance, VigiBase). - Conduct qualitative signal evaluation integrating data from spontaneous reports, clinical trials, post-authorization safety studies, scientific literature, social media monitoring, as applicable. - Prepare and review signal detection reports, signal evaluation reports, and signal management plans per client SOPs and regulatory expectations. - Ensure signal management activities are completed and reported within regulatory timelines to the appropriate entities (EMA, FDA, UK MHRA). - Oversee systematic medical literature searches (Embase, PubMed) and supervise triage and assessment of results for signal-relevant publications and ICSRs. - Collaborate with the aggregate reporting team on signal-related sections of PSURs/PBRERs and DSURs. - Contribute to Risk Management Plans (RMPs) and REMS as required. - Lead, supervise, and mentor PV Specialists and Sr. PV Specialists assigned to signal detection activities. - Develop and review SOPs and Work Instructions related to signal management in collaboration with the PV Quality Manager and the PV Medical Writing Manager. - Ensure inspection and audit readiness and actively support QA activities including CAPA follow-up. - Interact with the PV Physician and QPPV for scientific exchange pertaining to signal assessment and benefit-risk implications. - Comply with all applicable guidelines, policies, legal, regulatory, and compliance requirements. Qualifications - Advanced degree in pharmacy (PharmD preferred), medicine, life sciences, or epidemiology. - A postgraduate qualification in pharmacoepidemiology or drug safety is an advantage. Requirements - Minimum 4 years of PV experience, with at least 2 years focused on signal detection or pharmacoepidemiology at a PV vendor, CRO, or pharmaceutical company. - Hands-on experience with signal detection methods and regulatory safety databases (FAERS, EudraVigilance, VigiBase) required. - Safety databases (like Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube Safety), signal detection tools, literature databases (Embase, PubMed), Microsoft Office Suite. Familiarity with statistical tools is an advantage. Work Environment Remote: Romania / Poland or Portugal To apply for this role: - Step 1: Proceed to follow the form instructions - Step 2: Our HR team will review your application with feedback - Step 3: If successful, HR will arrange your Introductory call - Step 4: A potential online language assessment - Step 5: 1st formal interview - Step 6: 2nd formal interview - Step 7: Offer Disclaimer By attaching your Curriculum Vitae (CV), resume, and/or completing an online application, you are consenting to the collection, processing, use, transfer (including but not limited to other countries/jurisdictions), storage, and disclosure of your personal data as described in the Med Communications, Inc. Privacy Policy. Please read this policy carefully for more information on your rights regarding personal data protection. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status. Recruitment Agency Notice: Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs, as our in-house team manages all hiring processes. Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy. Should collaboration opportunities arise, we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.