About the role
Alphanumeric is hiring a SERM Medical Director (Remote, 1-Year Contract) to work for one of the biggest pharmaceutical companies in the world.
We are looking for a SERM Medical Director to support a global pharmaceutical organization's Safety Evaluation & Risk Management function. This role will provide medical leadership for the safety evaluation, benefit-risk assessment, and risk management of products in clinical development and post-marketing settings.
The ideal candidate will combine strong clinical development and pharmacovigilance expertise with the ability to independently assess safety issues, support regulatory interactions, and contribute to cross-functional decision-making.
Location
Remote, based in Brazil.
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 evaluation and benefit-risk assessments for assigned products.
Support pharmacovigilance and risk management activities across clinical development and marketed products.
Contribute to regulatory submissions and health authority interactions.
Prepare and review scientifically sound responses to Health Authority Requests for Information (RFIs).
Analyze and interpret clinical and safety data to support regulatory and business decisions.
Participate in cross-functional safety governance and product safety discussions.
Provide protocol and regulatory support throughout the development lifecycle.
Escalate significant safety concerns and emerging risks when appropriate.
Required Qualifications
MD or equivalent physician qualification.
Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions.
Experience responding to Health Authority RFIs.
Strong understanding of benefit-risk assessment and safety evaluation.
Experience supporting regulatory submissions and regulatory authority interactions.
Excellent scientific writing and communication skills. Proficiency in English is mandatory.
Ability to work independently in a fast-paced, highly matrixed environment.
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.
The SERM Medical Director will lead safety evaluations and benefit-risk assessments, providing medical leadership in clinical development and post-marketing risk management.
The Medical Director will lead safety evaluations and benefit-risk assessments, providing medical leadership for clinical development and post-marketing risk management.
The Medical Assessment and Signal Detection Lead is responsible for reviewing and approving Individual Case Safety Reports (ICSRs) and performing signal detection activities in collaboration with program safety leads.
The Sr. Medical Director, Drug Safety & Pharmacovigilance will lead safety strategy and risk management initiatives, ensuring compliance and effective evaluation of safety data for drug development projects.
The Medical Director will provide strategic medical leadership in clinical trial projects, focusing on endocrinology and regulatory activities while working independently on a part-time contract basis.
