Associate Scientific Director – SERM & Clinical Safety
Alphanumeric Systems
Descrição do cargo
About the role
Alphanumeric is seeking an Associate Scientific Director to lead safety evaluation, risk management and pharmacovigilance activities for global clinical development and post‑marketing programs. The role is fully remote and based in Brazil, supporting U.S. and U.K. business hours.
Key responsibilities
- Conduct safety reviews and risk‑management activities for assigned products, evaluating data from clinical trials, post‑marketing sources and scientific literature.
- Support global regulatory submissions, draft responses to Health Authority RFIs and provide protocol, safety and regulatory assistance to clinical development teams.
- Participate in cross‑functional safety governance, identify emerging safety concerns and recommend appropriate actions.
Required profile
- Advanced scientific or healthcare degree (PhD, PharmD, MS, NP, RN or equivalent).
- Significant experience in clinical development, drug safety or pharmacovigilance, including responding to Health Authority RFIs.
- Proficiency in English and ability to work independently within global teams.
Required skills
- Strong analytical and scientific writing abilities.
- Excellent communication skills for interaction with internal stakeholders and health authorities.
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Salários, guias e pesquisas em Brasil.
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Alphanumeric Systems
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