Scientific Director, SERM & Clinical Safety and Pharmacovigilance
A
AlphanumericPharmacovigilance
Remote, based in Brazil., Candidates must be available to work within U.S. and/or U.K. business time zones.ContractDirector
Salary not disclosed
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Job Details
- Languages
- Proficiency in English is mandatory.
- Required Skills
- Risk Management
Requirements
- Hold an advanced scientific or healthcare-related degree (PhD, PharmD, MS, NP, RN, or equivalent).
- Have significant experience in clinical development, drug safety, pharmacovigilance, or a related field.
- Have experience responding to Health Authority RFIs.
- Have strong protocol support and regulatory experience.
- Be proficient in English.
- Work independently and escalate issues appropriately when needed.
- Have experience working effectively within global cross-functional teams.
- Oncology experience is desirable but not required.
- Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies is preferred.
- Experience supporting global development programs is preferred.
Responsibilities
- Lead safety review and risk management activities for assigned products.
- Evaluate safety data from clinical trials, post-marketing sources, and scientific literature.
- Support global regulatory submissions and health authority interactions.
- Draft and review responses to Health Authority Requests for Information (RFIs).
- Provide protocol, safety, and regulatory support to clinical development teams.
- Participate in cross-functional safety governance and risk management activities.
- Identify emerging safety concerns and recommend appropriate actions.
- Collaborate with internal stakeholders to ensure scientifically sound and compliant safety strategies.
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