Medical Director (SERM & Clinical Safety & Pharmacovigilance) – Remote – Brazil
Alphanumeric Systems
Descrição do cargo
About the role
Alphanumeric is hiring a Medical Director for a 1‑year remote contract 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 clinical development and post‑marketing.
Key responsibilities
- Lead 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 clinical and safety data to support regulatory and business decisions.
- Participate in cross‑functional safety governance and product safety discussions.
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 is mandatory.
Required skills
- MD or equivalent medical qualification.
- Experience in clinical development and pharmacovigilance.
- Experience with regulatory interactions (FDA, EMA, PMDA, etc.).
What we offer
- Salary base plus benefits.
- Home office reimbursement.
- Private health insurance.
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Alphanumeric Systems