Scientific Director (SERM & Clinical Safety & Pharmacovigilance) – Remote – Brazil
Alphanumeric Systems
Descrição do cargo
About the role
Alphanumeric is seeking a Scientific Director to lead safety evaluation, risk management and pharmacovigilance activities for global clinical development and post‑marketing programs. The position is remote and based in Brazil, supporting a worldwide Safety Evaluation & Risk Management organization.
Key responsibilities
- Lead safety review and risk management for assigned products, evaluating data from clinical trials, post‑marketing sources and scientific literature.
- Support global regulatory submissions, interact with health authorities and draft responses to Requests for Information (RFIs).
- Provide protocol, safety and regulatory support to clinical development teams and participate in cross‑functional safety governance.
- Identify emerging safety concerns, recommend actions and ensure compliant safety strategies across global programs.
Required profile
- Advanced scientific or healthcare degree (PhD, PharmD, MS, NP, RN or equivalent).
- Significant experience in clinical development, drug safety, pharmacovigilance or related field, including responding to health authority RFIs.
- Strong analytical, scientific writing and communication abilities; proficiency in English is mandatory.
- Ability to work independently, escalate issues appropriately and collaborate within global cross‑functional teams.
Required skills
- Scientific leadership in safety evaluation and risk management.
- Regulatory support experience for global submissions.
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Alphanumeric Systems
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