Director, Advanced Safety Analytics & Pharmacoepidemiologic Strategy

Job Description

The position

The Director, Advanced Safety Analytics & Pharmacoepidemiologic Strategy, will serve as a senior expert within the Global Medical Safety organization, supporting the evaluation and refinement of advanced pharmacoepidemiologic methods applied to safety signal detection, real-world data analytics, and benefit-risk assessment. The role emphasizes the application of rigorous quantitative methodologies to enhance signal evaluation strategies across the product lifecycle, with a particular focus on the development and implementation of analytical tools for use in regulatory and clinical safety decision-making.

Organizational Relationships: Reports to the Therapeutic Area Leads - Global Medical Safety, Global Pharmacovigilance.

Responsibilities

• Contribute scientific expertise to the design and application of advanced quantitative methods for safety signal detection and evaluation.

• Lead/Support the development and enhancement of internal tools and platforms for analyzing spontaneous reports, observed-to-expected analyses, and other pharmacoepidemiologic methodologies.

• Conduct sophisticated analyses leveraging real-world data sources (e.g., FAERS, healthcare claims, electronic health records) to support signal evaluation and contextualize safety findings.

• Collaborate closely with Safety Leads, Biostatistics, Regulatory Affairs, and Clinical teams to develop robust epidemiologic analyses for regulatory submissions, including PSURs, RMPs, and SERs.

• Develop and maintain dashboards and analytic solutions (e.g., in R Shiny, Spotfire) to support internal signal monitoring and safety review committees.

• Drive initiatives to standardize and automate safety signal analytics processes ensuring efficiency and consistency.

• Expand the scope of safety data for developing competitive safety intelligence and facilitate head-to-head comparison of benefit-risk profiles with competitors.

• Contribute and influence the system roadmap to ensure that the appropriate tools are available to sustain signal detection and evaluation activities in a scalable way (data centralization, complementarity of tools, possibilities of automation, qualification of the reports for GxP purposes)

• Support dissemination of scientific findings through internal documentation/guidance and trainings, external presentations, and peer-reviewed publications, to contribute to the broader scientific community.

Tasks

• Apply advanced quantitative methods to detect, assess, and characterize safety signals using routine and targeted disproportionality analysis, observed-to-expected (O/E) comparisons, time-to-onset signalling, and other epidemiologic approaches across spontaneous and observational data sources.

• Perform complex analyses using real-world data sources (e.g., FAERS,  healthcare claims, EHRs) to support safety signal evaluations.

• Actively contribute to the development and refinement of structured benefit-risk evaluations, integrating pharmacoepidemiologic evidence into the clinical and regulatory interpretation of safety data.

• Provide scientific support for the quantitative underpinning of benefit-risk assessments in regulatory documents (e.g., PSURs, RMPs, SERs, ACOs), including contextualization of incidence rates, estimation of absolute and relative risk, and derivation of impact metrics.

• Design and maintain internal epidemiologic tools and dashboards (e.g., in R Shiny or Spotfire) to support signal triage, time trends visualization, incidence benchmarking, and benefit-risk communication.

• Collaborate with safety leads, clinical development, and regulatory teams to identify, interpret, and communicate key epidemiologic insights relevant to drug safety and risk management planning.

• Serve as internal scientific advisor for real-world evidence strategies in the post-marketing setting, including the generation and use of background rates, validation cohorts, and simulation models.

• Provide technical and scientific support for safety-related decision-making processes.

• Author and review pharmacoepidemiologic sections of regulatory deliverables, ensuring methodological rigor, clarity, and alignment with global expectations (EMA, FDA, PMDA).

• Contribute to the standardization and documentation of analytical methodologies used for signal assessment and benefit-risk evaluations, ensuring audit readiness and reproducibility.

• Establish best practices for consistent and efficient signal detection and analysis.

• Monitor scientific and regulatory developments in the field of benefit-risk and signal detection, integrating relevant innovations into internal processes and frameworks.

• Present findings at external conferences and contribute to peer-reviewed publications to share insights with the broader scientific community.

Required Education, Experience, and Skills

• In-depth knowledge in pharmacoepidemiology and advanced quantitative signal detection methods.

• High-level proficiency in data visualization, analytics, and scientific programming.

• Strong understanding of regulatory requirements and safety deliverables (e.g., PSURs/PBRERs, RMPs, SERs).

• Strong expertise in analytical tools and programming languages (e.g., R, Python, SAS) and with developing dashboards and analytic solutions (e.g., R Shiny, Spotfire).

• Strong ability to translate complex data into actionable scientific and regulatory insight, strong critical thinking skills to contextualize safety findings and interpret data effectively.

• Familiarity with global regulatory guidelines and standards for signal detection, safety evaluations and benefit-risk assessment.

• Excellent collaboration and scientific communication skills.

• Initiative, scientific curiosity, and problem-solving orientation in the context of patient safety.

• Proficiency in advanced quantitative methods (disproportionality, time-to-onset, logistic regression, OE analyses, vigipoint, cluster analysis).

• Strong command of R (including R Shiny), Python, SAS, and data visualization tools (Spotfire).

• Solid understanding of spontaneous reporting systems and real-world evidence data landscapes.

• Experience with regulatory frameworks (FDA, EMA, PMDA) regarding safety signal detection and pharmacoepidemiology.

• Excellent documentation and scientific writing skills.

• Familiarity with structured benefit-risk methodologies such as BRAT, MCDA, NNT-based frameworks, and FDA/EMA BR guidance.

• At least 8–10 years of experience in pharmacoepidemiology, pharmacovigilance analytics, or related fields.

• Proven track record in developing and applying quantitative tools for post-marketing or clinical safety.

• Experience in building or contributing to analytic platforms or dashboards for internal use.

• Demonstrated scientific output (e.g., peer-reviewed publications, conference presentations).

• MSc in Mathematical Physics, Applied Statistics, Pharmacoepidemiology, or other relevant quantitative scientific field is required.

• PhD in Epidemiology, Biostatistics, Health Outcomes Research, or related area is considered a strong asset but not mandatory.

• Documented post-graduate training or certification in pharmacoepidemiologic methods, pharmacovigilance, or real-world data analytics (e.g., through academic courses, professional societies, or industry-recognized programs) is highly desirable.

• Formal training in Python programming, R (including R Shiny), and SAS is expected.

• Completion of certification or continuing education in regulatory science, benefit-risk assessment methodologies, or real-world evidence generation will be considered a plus.

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

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Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

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