Remote Medical Director, Safety & Risk Management

Alphanumeric Systems

Philippines

Remote

PHP 11,307,000 - 17,588,000

Full time

13 days ago
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Job summary

Alphanumeric Systems is seeking a SERM Medical Director for a remote, 1-year contract to lead safety evaluation and risk management for a global pharmaceutical program. The role requires MD or equivalent and deep expertise in clinical development and pharmacovigilance, with the ability to manage RFIs and regulatory interactions across worldwide teams.

The position demands strong scientific writing and communication skills, English fluency, and the capacity to work independently in a fast-paced,

Qualifications

  • MD or equivalent physician qualification required.
  • Extensive experience in clinical development, drug safety and pharmacovigilance.
  • Experience responding to Health Authority RFIs and regulatory submissions.
  • Strong benefit-risk assessment and safety evaluation expertise.
  • Proven ability to work independently in a fast-paced, matrixed environment and fluent English.

Responsibilities

  • Lead safety evaluation and benefit-risk assessments for assigned products.
  • Support pharmacovigilance and risk management across development and marketed products.
  • Contribute to regulatory submissions and regulatory authority interactions.
  • Prepare and review responses to Health Authority RFIs.
  • Analyze and interpret clinical and safety data to support 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.

Skills

Clinical development
Pharmacovigilance
RFI experience
Scientific writing
English proficiency
Independent work
Regulatory interactions

Education

MD or equivalent physician qualification

Job description

Alphanumeric Systems is seeking a SERM Medical Director for a remote, 1-year contract to lead safety evaluation and risk management for a global pharmaceutical program. The role requires MD or equivalent and deep expertise in clinical development and pharmacovigilance, with the ability to manage RFIs and regulatory interactions across worldwide teams.

The position demands strong scientific writing and communication skills, English fluency, and the capacity to work independently in a fast-paced,

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