About this role
About the role
Alphanumeric is hiring a SERM Associate Medical Director (Remote, 1-Year Contract with possibility of extension) to work for one of the biggest pharmaceutical companies in the world.
We are looking for a SERM Associate 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 and conditions
Full-Time | 1-Year Contract | Potential Extension
Model: 100% from home.
Salary base + benefits (home office reimbursement up to 50 eur gross per month + Health insurance for the worker + Meal Allowance according with the local labor law + Life insurance)
Working Hours
Candidates must be available to work within U.S. and/or U.K. business time zones.
Key Responsibilities
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Contribute to safety evaluation and benefit-risk assessments for assigned products.
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Support pharmacovigilance and risk management activities across clinical development and marketed products.
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Contribute to regulatory submissions and health authority interactions.
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Prepare and review scientifically sound responses to Health Authority Requests for Information (RFIs).
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Analyze and interpret clinical and safety data to support regulatory and business decisions.
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Participate in cross-functional safety governance and product safety discussions.
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Provide protocol and regulatory support throughout the development lifecycle.
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Identify and escalate significant safety concerns and emerging risks when appropriate.
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Required Qualifications
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MD or equivalent physician qualification.
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Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions.
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Experience responding to Health Authority RFIs.
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Strong understanding of benefit-risk assessment and safety evaluation.
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Experience supporting regulatory submissions and regulatory authority interactions.
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Excellent scientific writing and communication skills. Proficiency in English is mandatory.
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Ability to work independently in a fast-paced, highly matrixed environment.
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Preferred Qualifications
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Oncology experience is highly desirable but not required.
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Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies.
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Experience supporting global development programs.