Alphanumeric Systems
Medical Director (SERM & Clinical Safety & Pharmacovigilance) - Remote - Based in the Philippines
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About the Role
Alphanumeric is hiring a SERM Medical Director (Remote, 1-Year Contract) to work for one of the biggest pharmaceutical companies in the world.
We are looking for a SERM Medical Director to support a global pharmaceutical organization's Safety Evaluation & Risk Management function. This role will provide medical leadership for the safety evaluation, benefit-risk assessment, and risk management of products in clinical development and post-marketing settings.
The ideal candidate will combine strong clinical development and pharmacovigilance expertise with the ability to independently assess safety issues, support regulatory interactions, and contribute to cross-functional decision-making.
Location
Remote, based in the Philippines.
Employment Type
Full-Time | 1-Year Contract | Potential Extension
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Working Hours
Candidates must be available to work within U.S. and/or U.K. business time zones.
Key Responsibilities
- Lead safety evaluation and benefit-risk assessments for assigned products.
- Support pharmacovigilance and risk management activities across clinical development and marketed products.
- Contribute to regulatory submissions and health authority interactions.
- Prepare and review scientifically sound responses to Health Authority Requests for Information (RFIs).
- Analyze and interpret clinical and safety data to support regulatory and business decisions.
- Participate in cross-functional safety governance and product safety discussions.
- Provide protocol and regulatory support throughout the development lifecycle.
- Escalate significant safety concerns and emerging risks when appropriate.
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Required Qualifications
- MD or equivalent physician qualification.
- Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions.
- Experience responding to Health Authority RFIs.
- Strong understanding of benefit-risk assessment and safety evaluation.
- Experience supporting regulatory submissions and regulatory authority interactions.
- Excellent scientific writing and communication skills. Proficiency in English is mandatory.
- Ability to work independently in a fast-paced, highly matrixed environment.
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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