Alphanumeric Systems
Scientific Director (SERM & Clinical Safety & Pharmacovigilance) - Remote - Based in the Philippines
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About the role
Alphanumeric is seeking a SERM Scientific Director to support a global Safety Evaluation & Risk Management organization. This role is responsible for providing scientific leadership in the evaluation of product safety, benefit-risk management, and pharmacovigilance activities across clinical development and post-marketing programs.
The successful candidate will be a strong scientific leader capable of independently managing safety issues, supporting regulatory activities, and contributing to strategic safety decision-making across global programs.
Location
Remote, based in the Philippines.
Employment Type
- Full-Time
- 1-Year Contract
- Potential Extension
Working Hours
Candidates must be available to work within U.S. and/or U.K. business time zones.
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Key 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.
Required Qualifications
- Advanced scientific or healthcare-related degree (PhD, PharmD, MS, NP, RN, or equivalent).
- Significant experience in clinical development, drug safety, pharmacovigilance, or a related field.
- Experience responding to Health Authority RFIs.
- Strong protocol support and regulatory experience.
- Excellent analytical, scientific writing, and communication skills. Proficiency in English is mandatory.
- Ability to work independently and appropriately escalate issues when needed.
- Experience working effectively within global cross-functional teams.
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Preferred Qualifications
- Oncology experience is highly desirable but not required.
- Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies.
- Experience supporting global development programs.
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