Remote Scientific Director – Safety & Pharmacovigilance (SERM)

Alphanumeric Systems

Polska

Remote

PLN 450,000 - 550,000

Full time

6 days ago
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Benefits offered by this job

Internet allowance
Health insurance

Job summary

Alphanumeric is seeking a SERM Scientific Director to lead safety evaluation and risk management across global programs. You will guide pharmacovigilance activities, support regulatory submissions, and shape strategic safety decisions within a remote, Poland-based role.

The role requires expert scientific leadership, experience with health authorities, and strong English communication. Expect 100% remote work with a 1-year contract and potential extension.

Qualifications

  • Advanced scientific or healthcare 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.

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 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

Skills

Clinical development experience
Pharmacovigilance
Regulatory affairs
Scientific writing
Communication skills
English proficiency

Education

Advanced scientific or healthcare degree

Job description

Alphanumeric is seeking a SERM Scientific Director to lead safety evaluation and risk management across global programs. You will guide pharmacovigilance activities, support regulatory submissions, and shape strategic safety decisions within a remote, Poland-based role.

The role requires expert scientific leadership, experience with health authorities, and strong English communication. Expect 100% remote work with a 1-year contract and potential extension.

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