1,059 Pharmaceutical Regulations jobs in the United States

• Monitor and evaluate safety data for assigned investigational and marketed pharmaceutical products.
• Perform comprehensive case processing, including assessment of causality, seriousness, and expectedness of adverse events.
• Ensure timely and accurate submission of safety reports to regulatory authorities worldwide (e.g., FDA, EMA).
• Contribute to the preparation of periodic safety update reports (PSURs/PBRERs) and other regulatory documents.
• Participate in safety risk management activities, including the development and implementation of risk management plans (RMPs).
• Collaborate with clinical operations, medical affairs, and regulatory teams on safety-related matters.
• Review and interpret clinical trial data for safety signals and trends.
• Develop and maintain a deep understanding of product-specific safety profiles and relevant therapeutic areas.
• Contribute to the development and execution of pharmacovigilance strategies.
• Stay current with evolving global pharmacovigilance regulations and guidelines.

• Bachelor's degree in a life science, nursing, pharmacy, or a related healthcare field. Advanced degree (Master's, Pharm.D., M.D.) preferred.
• Minimum of 5 years of experience in drug safety, pharmacovigilance, or a related clinical safety role within the pharmaceutical industry.
• In-depth knowledge of global regulatory requirements for adverse event reporting (e.g., ICH E2B, E2C, E2D).
• Experience with safety databases and electronic data capture (EDC) systems.
• Strong clinical or scientific background with the ability to critically evaluate medical information.
• Excellent analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with the ability to clearly articulate complex safety information.
• Proven ability to manage multiple priorities and meet strict deadlines in a remote environment.
• Team player with strong interpersonal skills and the ability to collaborate effectively.

• Provide medical expertise for drug safety surveillance and signal detection.
• Lead the assessment of adverse event data and develop safety narratives.
• Contribute to the development and review of regulatory submissions related to drug safety.
• Prepare and review safety sections of clinical study documents, Investigator's Brochures, and Core Data Sheets.
• Liaise with regulatory health authorities on safety matters.
• Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Medical Affairs.
• Provide medical input into risk management plans and pharmacovigilance strategies.
• Mentor and guide junior medical safety professionals.
• Stay current with global regulatory requirements and guidelines for pharmacovigilance.

• Medical Doctor (MD) or Doctor of Osteopathic Medicine (DO) degree.
• Board certification in a relevant medical specialty (e.g., Internal Medicine, Pharmacology, Toxicology) is highly desirable.
• Minimum of 8 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
• In-depth knowledge of global regulatory requirements for drug safety and pharmacovigilance.
• Strong clinical acumen and ability to interpret complex medical and scientific data.
• Excellent written and verbal communication skills, with experience in regulatory interactions.
• Proven ability to lead projects and collaborate effectively within a team environment.

• Lead the safety surveillance activities for assigned pharmaceutical products throughout their lifecycle.
• Develop and implement robust signal detection and evaluation strategies.
• Conduct comprehensive safety data analysis, including periodic and ad-hoc reviews.
• Prepare and review aggregate safety reports (e.g., PBRERs, DSURs) for submission to regulatory authorities.
• Contribute to the development and maintenance of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
• Act as the primary safety representative in cross-functional teams, including clinical development, regulatory affairs, and medical affairs.
• Interpret complex safety data and provide clear, concise recommendations to management and regulatory bodies.
• Ensure compliance with global pharmacovigilance regulations and guidelines.
• Mentor and guide junior safety scientists and contribute to the growth of the pharmacovigilance department.
• Stay abreast of evolving regulatory requirements and scientific advancements in drug safety.
• Manage vendor relationships related to safety data collection and processing.

• Ph.D. or Pharm.D. from an accredited institution; MD also considered.
• A minimum of 10 years of progressive experience in drug safety, pharmacovigilance, or clinical safety assessment within the pharmaceutical industry.
• In-depth knowledge of global regulatory requirements for pharmacovigilance (e.g., FDA, EMA).
• Proven expertise in signal detection, benefit-risk assessment, and aggregate safety reporting.
• Strong analytical skills with the ability to interpret large datasets and draw scientifically sound conclusions.
• Excellent written and verbal communication skills, with a track record of producing high-quality regulatory documents.
• Demonstrated leadership capabilities and experience managing projects or teams.
• Ability to work independently, prioritize tasks effectively, and manage multiple projects in a remote setting.
• Proficiency in safety databases and data analysis tools.
• Experience with specific therapeutic areas is a plus.

• Lead the medical assessment of adverse event reports, determining causality and clinical significance.
• Participate in signal detection activities, identifying potential new safety concerns.
• Contribute to the development and implementation of risk management plans (RMPs) and risk evaluation and mitigation strategies (REMS).
• Author and review aggregate safety reports, such as Periodic Adverse Drug Experience Reports (PADERs) and Development Safety Update Reports (DSURs).
• Provide medical input for clinical trial protocols, Investigator's Brochures (IBs), and informed consent forms related to safety aspects.
• Serve as the medical expert on drug safety committees and working groups.
• Collaborate with regulatory affairs to ensure timely and accurate submission of safety information to health authorities.
• Mentor and provide medical guidance to junior physicians, case managers, and safety scientists.
• Liaise with clinical development teams to ensure ongoing assessment of drug benefit-risk profiles.
• Stay current with global regulatory requirements and industry best practices in pharmacovigilance.
• Participate in due diligence activities for potential business development opportunities from a safety perspective.

• Medical Degree (MD, DO, or equivalent) with active medical license.
• Board Certification in a relevant clinical specialty is highly desirable.
• Minimum of 7 years of experience in drug safety and pharmacovigilance within the pharmaceutical or biotechnology industry.
• Comprehensive knowledge of global regulatory requirements for drug safety (e.g., FDA, EMA, ICH guidelines).
• Proven experience in signal detection, risk assessment, and management.
• Strong clinical acumen and ability to interpret complex medical data.
• Excellent medical writing skills, with the ability to author clear and concise safety documents.
• Strong leadership, communication, and interpersonal skills.
• Ability to work effectively in a remote, collaborative, and fast-paced global environment.
• Experience with safety databases and reporting systems.

The Senior Medical Director, Clinical Safety will provide strategic medical safety leadership for benefit-risk assessments of investigational products, with a particular focus on a key biologic asset in development for one of the company's leading products. Operating within a matrixed environment, this role oversees safety-related activities across the clinical development portfolio, including signal detection, risk evaluation, mitigation planning, and aggregate safety reporting.

This position also leads the medical review of safety content in clinical documentation such as study protocols, investigator brochures, clinical study reports, product labeling, and regulatory responses.

Additionally, the Senior Medical Director will manage a global team of pharmacovigilance professionals dedicated to clinical development safety activities.

• Develop and maintain Development Risk Management Plans (DRMPs) to proactively minimize risks during clinical trials.
• Collaborate with internal and external stakeholders to monitor safety profiles, validate and evaluate safety signals, and recommend appropriate risk mitigation strategies.
• Lead the preparation and submission of aggregate safety reports (e.g., DSURs, PSURs, PBRERs).
• Own the development and maintenance of Risk Management Plans (RMPs).
• Provide expert input into safety sections of regulatory dossiers and contribute to responses to safety-related inquiries from health authorities and other stakeholders.
• Participate in investigator and key opinion leader (KOL) meetings to address safety-related topics.
• Oversee ongoing safety data review during clinical trials through structured Safety Plans and regular safety review meetings.
  
  

• M.D. required; additional qualifications in Clinical Pharmacology, Public Health, Epidemiology, or Pharmacovigilance preferred.
• Minimum of 12 years of experience in drug development, clinical safety, or pharmacovigilance within a global pharmaceutical organization.
• At least 3-5 years of experience managing teams of safety physicians or scientists.
• Deep understanding of international clinical development and post-marketing safety regulations, particularly for biologics.
• Proven experience interacting with global health authorities on safety-related matters (e.g., RMPs, Clinical Overviews).
• Strong knowledge of global safety requirements across the product life cycle.

The Senior Medical Director, Clinical Safety will provide strategic medical safety leadership for benefit-risk assessments of investigational products, with a particular focus on a key biologic asset in development for one of the company's leading products. Operating within a matrixed environment, this role oversees safety-related activities across the clinical development portfolio, including signal detection, risk evaluation, mitigation planning, and aggregate safety reporting.

This position also leads the medical review of safety content in clinical documentation such as study protocols, investigator brochures, clinical study reports, product labeling, and regulatory responses.

Additionally, the Senior Medical Director will manage a global team of pharmacovigilance professionals dedicated to clinical development safety activities.

• Develop and maintain Development Risk Management Plans (DRMPs) to proactively minimize risks during clinical trials.
• Collaborate with internal and external stakeholders to monitor safety profiles, validate and evaluate safety signals, and recommend appropriate risk mitigation strategies.
• Lead the preparation and submission of aggregate safety reports (e.g., DSURs, PSURs, PBRERs).
• Own the development and maintenance of Risk Management Plans (RMPs).
• Provide expert input into safety sections of regulatory dossiers and contribute to responses to safety-related inquiries from health authorities and other stakeholders.
• Participate in investigator and key opinion leader (KOL) meetings to address safety-related topics.
• Oversee ongoing safety data review during clinical trials through structured Safety Plans and regular safety review meetings.
  

• M.D. required; additional qualifications in Clinical Pharmacology, Public Health, Epidemiology, or Pharmacovigilance preferred.
• Minimum of 12 years of experience in drug development, clinical safety, or pharmacovigilance within a global pharmaceutical organization.
• At least 3-5 years of experience managing teams of safety physicians or scientists.
• Deep understanding of international clinical development and post-marketing safety regulations, particularly for biologics.
• Proven experience interacting with global health authorities on safety-related matters (e.g., RMPs, Clinical Overviews).
• Strong knowledge of global safety requirements across the product life cycle.

The Senior Medical Director, Clinical Safety will provide strategic medical safety leadership for benefit-risk assessments of investigational products, with a particular focus on a key biologic asset in development for one of the company's leading products. Operating within a matrixed environment, this role oversees safety-related activities across the clinical development portfolio, including signal detection, risk evaluation, mitigation planning, and aggregate safety reporting.

This position also leads the medical review of safety content in clinical documentation such as study protocols, investigator brochures, clinical study reports, product labeling, and regulatory responses.

Additionally, the Senior Medical Director will manage a global team of pharmacovigilance professionals dedicated to clinical development safety activities.

• Develop and maintain Development Risk Management Plans (DRMPs) to proactively minimize risks during clinical trials.
• Collaborate with internal and external stakeholders to monitor safety profiles, validate and evaluate safety signals, and recommend appropriate risk mitigation strategies.
• Lead the preparation and submission of aggregate safety reports (e.g., DSURs, PSURs, PBRERs).
• Own the development and maintenance of Risk Management Plans (RMPs).
• Provide expert input into safety sections of regulatory dossiers and contribute to responses to safety-related inquiries from health authorities and other stakeholders.
• Participate in investigator and key opinion leader (KOL) meetings to address safety-related topics.
• Oversee ongoing safety data review during clinical trials through structured Safety Plans and regular safety review meetings.
  
  

• M.D. required; additional qualifications in Clinical Pharmacology, Public Health, Epidemiology, or Pharmacovigilance preferred.
• Minimum of 12 years of experience in drug development, clinical safety, or pharmacovigilance within a global pharmaceutical organization.
• At least 3-5 years of experience managing teams of safety physicians or scientists.
• Deep understanding of international clinical development and post-marketing safety regulations, particularly for biologics.
• Proven experience interacting with global health authorities on safety-related matters (e.g., RMPs, Clinical Overviews).
• Strong knowledge of global safety requirements across the product life cycle.