About the role
Alphanumeric is seeking a SERM Scientific Director to support a global Safety Evaluation & Risk Management organization. This role is responsible for providing scientific leadership in the evaluation of product safety, benefit-risk management, and pharmacovigilance activities across clinical development and post-marketing programs.
The successful candidate will be a strong scientific leader capable of independently managing safety issues, supporting regulatory activities, and contributing to strategic safety decision-making across global programs.
Expertise in some of the following therapeutic areas are requested: Classic Established products, Oncology, Respiratory, Immunology, Inflammation, Vaccines and Infectious Disease.
Location
Remote, based in India.
Employment Type
Full-Time | 1-Year Contract | Potential Extension
Working Hours
Candidates must be available to work within U.S. and/or U.K. business time zones.
Key Responsibilities
Lead safety review and risk management activities for assigned products.
Evaluate safety data from clinical trials, post-marketing sources, and scientific literature.
Support global regulatory submissions and health authority interactions.
Draft and review responses to Health Authority Requests for Information (RFIs).
Provide protocol, safety, and regulatory support to clinical development teams.
Participate in cross-functional safety governance and risk management activities.
Identify emerging safety concerns and recommend appropriate actions.
Collaborate with internal stakeholders to ensure scientifically sound and compliant safety strategies
Required Qualifications
Advanced scientific or healthcare-related degree (PhD, PharmD, MS, NP, RN, or equivalent).
Significant experience in clinical development, drug safety, pharmacovigilance, or a related field.
Experience responding to Health Authority RFIs.
Strong protocol support and regulatory experience.
Excellent analytical, scientific writing, and communication skills. Proficiency in English is mandatory.
Ability to work independently and appropriately escalate issues when needed.
Experience working effectively within global cross-functional teams
Preferred Qualifications
Oncology experience is highly desirable but not required.
Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies.
Experience supporting global development programs.
Provides medical leadership for safety evaluation, benefit-risk assessment, and risk management across clinical development and marketed products, supporting regulatory interactions and cross-functional safety decisions.
Provides medical leadership for safety evaluation, benefit-risk assessment, and risk management across clinical development and marketed products, supporting regulatory interactions and cross-functional safety decisions.
Oversee clinical operations and physician services, advise providers on complex cases, monitor care quality and patient safety, and improve protocols and workflows across the practice.
Provides clinical guidance to physicians and advanced practice providers, reviews complex cases and performance concerns, and supports provider development, clinical standards, and consistent treatment decisions.
Leads clinical quality and patient safety reviews by evaluating care, investigating concerns, participating in peer review, and guiding providers on corrective measures and improvement initiatives.
