Associate Medical Director – SERM & Clinical Safety (Remote, Brazil)
Alphanumeric Systems
Descrição do cargo
About the role
Alphanumeric Systems is hiring a SERM Associate Medical Director on a 1‑year contract (with possible extension) to support a global pharmaceutical company's Safety Evaluation & Risk Management function. The role provides medical leadership for safety evaluation, benefit‑risk assessment, and risk management of products in both clinical development and post‑marketing settings.
Key responsibilities
- Contribute to safety evaluation and benefit‑risk assessments for assigned products.
- Support pharmacovigilance and risk‑management activities across clinical development and marketed products.
- 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.
- Identify and escalate significant safety concerns and emerging risks when appropriate.
Required profile
- MD or equivalent physician qualification.
- Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions.
- Experience responding to Health Authority RFIs and supporting regulatory submissions.
- Strong understanding of benefit‑risk assessment and safety evaluation.
- Excellent scientific writing and communication skills.
- Proficiency in English and ability to work independently in a fast‑paced, matrixed environment.
Required skills
- Medical degree (MD) or equivalent.
- English proficiency (mandatory).
- Scientific writing.
What we offer
- Salary base plus benefits.
- Home office reimbursement up to €50 gross per month.
- Health insurance for the worker.
- Meal allowance according to local labor law.
- Life insurance.
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Alphanumeric Systems
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