Remote SERM Safety & PV Scientific Director (1-Year)

Alphanumeric Systems; Philippines; Remote; PHP 7,538,000 - 11,307,000; Full time

Job summary

Alphanumeric Systems is seeking a SERM Scientific Director to lead safety evaluation and risk management across global programs. This remote role, based in the Philippines, requires steering pharmacovigilance activities and supporting regulatory interactions in a high-stakes environment.

Responsibilities include evaluating safety data, coordinating with cross-functional teams, and drafting responses to Health Authority RFIs while ensuring scientifically sound safety strategies.

Qualifications

• Advanced scientific or healthcare-related degree required.
• Significant experience in clinical development, drug safety, or pharmacovigilance.
• Experience responding to Health Authority RFIs.
• Strong protocol support and regulatory experience.
• Excellent analytical and scientific writing and communication skills.
• Proficiency in English is mandatory.
• Ability to work independently and escalate where needed.
• Experience with global cross-functional teams.

Responsibilities

• Lead safety review and risk management activities for assigned products.
• Evaluate safety data from trials, post-marketing sources, and literature.
• Support global regulatory submissions and health authority interactions.
• Draft and review responses to Health Authority RFIs.
• Provide protocol, safety, and regulatory support to clinical teams.
• Participate in cross-functional safety governance and risk management.
• Identify emerging safety concerns and recommend actions.
• Collaborate with stakeholders to ensure compliant safety strategies.

Skills

Clinical development

Drug safety

Pharmacovigilance

Health Authority RFIs

Regulatory experience

Analytical skills

Scientific writing

Communication skills

Team collaboration

Education

PhD/PharmD/MS/NP/RN or equivalent

Job description

Alphanumeric Systems is seeking a SERM Scientific Director to lead safety evaluation and risk management across global programs. This remote role, based in the Philippines, requires steering pharmacovigilance activities and supporting regulatory interactions in a high-stakes environment.

Responsibilities include evaluating safety data, coordinating with cross-functional teams, and drafting responses to Health Authority RFIs while ensuring scientifically sound safety strategies.