Medical Director, Patient Safety and Pharmacovigilance (PSPV), Marketed Products Medical Development (MPMD)

Accountabilities:

• • Serve as the Global Safety Lead and senior patient-safety subject matter expert for assigned pharmaceutical, biological, and drug-device combination products, defining and executing safety strategies throughout the product lifecycle.
  • Lead Global Safety Teams and Safety Management Teams, establishing safety priorities, driving timely decisions, and maintaining clear accountability across functions.
  • Evaluate and interpret safety information from clinical and non-clinical studies, post-marketing data, real-world evidence, scientific literature, and other relevant sources.
  • Lead signal detection, monitoring, evaluation, interpretation, and management in accordance with global pharmacovigilance requirements and internal procedures.
  • Direct cross-functional benefit-risk assessments and ensure accurate, consistent, and timely communication of safety information to senior leadership, governance bodies, regulatory authorities, and other stakeholders.
  • Develop and lead scientifically robust responses to safety-related inquiries from regulatory agencies and ethics committees, ensuring materials are consistent and inspection-ready.
  • Provide medical safety expertise and review or author safety-related sections of key regulatory and clinical documents, including protocols, investigator brochures, clinical study reports, safety evaluation reports, regulatory submissions, and health hazard assessments.
  • Integrate patient-safety considerations into clinical development programs, including study design, statistical analysis planning, safety endpoints, and overall safety characterization.
  • Develop, maintain, and communicate product benefit-risk profiles and associated risk-management documentation, including Risk Management Plans.
  • Partner with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, Legal, and other functions to align safety messaging and decision-making.
  • Support interactions with regulatory authorities and help develop and defend safety positions during submissions, inspections, and regulatory discussions.
  • Ensure safety information remains current across core data sheets, reference safety information, investigator brochures, labeling, and other relevant documents.
  • Monitor evolving regional and international pharmacovigilance regulations and incorporate changing safety expectations into product strategies.
  • Support a high-performing, compliant, and inspection-ready global safety organization through strong governance and consistent application of pharmacovigilance standards.
  • Mentor and provide scientific guidance to Pharmacovigilance Physicians and Safety Scientists, strengthening organizational capabilities and consistency of safety assessments.
  • Maintain professional expertise through continuing medical education and contribute to a culture of scientific excellence and continuous learning.
  • Explore quantitative methodologies and emerging technologies, including AI, to strengthen signal detection and safety surveillance while maintaining scientific rigor and regulatory acceptability.

  Requirements:

  • Medical degree such as an M.D., D.O., or internationally recognized equivalent, with relevant clinical experience following postgraduate training and strong knowledge of general medicine, epidemiology, and biostatistics; board certification and professional licensure are preferred.
  • At least 5 years of experience in Drug Safety or Pharmacovigilance, including 3 or more years in post-marketing safety, with demonstrated expertise in aggregate reporting, safety surveillance, signal management, safety labeling, benefit-risk assessment, and risk management.
  • Strong knowledge of national and international pharmacovigilance and regulatory frameworks, including relevant FDA, EMA, PMDA, and ICH guidelines.
  • Experience responding to safety-related questions and requests from regulatory authorities and other external stakeholders.
  • Strong scientific judgment and the ability to make sound, defensible decisions when working with uncertainty, incomplete evidence, or emerging safety signals.
  • Excellent written and verbal communication skills, with the ability to translate complex medical and safety concepts clearly across technical and non-technical audiences.
  • Demonstrated ability to influence without direct authority and build alignment across global, matrixed, cross-functional teams.
  • Strong prioritization, organization, and independent working skills, with the ability to manage multiple priorities and deliver commitments with limited supervision.
  • Collaborative mindset with strong relationship-building and stakeholder-management capabilities, particularly in high-visibility and high-stakes governance environments.
  • Ability to assess the benefit-risk implications of strategic options and develop a broader understanding of business considerations beyond core pharmacovigilance responsibilities.
  • Willingness and ability to travel locally and internationally as required for business needs.
  • Flexibility to occasionally support activities aligned with the U.S. Eastern Time Zone to facilitate global collaboration and urgent regulatory responses.

  Benefits:

  • Competitive salary with an annual performance-based bonus.
  • Flexible and remote-friendly work environment, in accordance with the organization's hybrid and remote-work policies.
  • Comprehensive healthcare insurance coverage for employees, spouses, and children.
  • Group term life insurance and group accident insurance.
  • Health and wellness initiatives, including annual health screenings and regular employee wellness sessions.
  • Employee Assistance Program.
  • Five days of annual leave for voluntary service, in addition to humanitarian leave provisions.
  • Access to a broad range of learning and professional development platforms.
  • Diversity, Equity, and Inclusion programs supporting an inclusive workplace.
  • Designated no-meeting days to support focused and productive work.
  • Home internet and mobile phone reimbursements.
  • Employee referral program.
  • Paid parental leave, including up to 26 weeks of maternity leave and 4 weeks of paternity leave.
  • Bereavement leave of up to 5 days.
  • Full-time, regular employee position based in Bengaluru, India, with remote flexibility.
  • Opportunity to work in a global, science-driven environment with meaningful impact on patient safety and medicine development.