Remote SERM Safety Director, Global Pharmacovigilance Lead

Alphanumeric; Polska; Hybrid; PLN 450,000 - 550,000; Full time

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, including pharmacovigilance activities in clinical development and post-marketing.

This remote role is based in Poland, with a 1-year contract and potential extension. Salary base 450,000 - 550,000 PLN gross per year. You will work across US/UK business hours and interact with regulatory agencies as needed.

Qualifications

• Advanced scientific or healthcare degree.
• Significant experience in clinical development, drug safety or pharmacovigilance.
• 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 escalate issues when needed.

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 development teams.
• Participate in cross-functional safety governance and risk management activities.
• Identify emerging safety concerns and recommend actions.
• Collaborate with internal stakeholders to ensure safety strategies are scientifically sound.

Skills

Analytical skills

Scientific writing

Communication skills

English proficiency

Education

Advanced degree (PhD/PharmD/MS/NP/RN)

Job description

Alphanumeric is seeking a SERM Scientific Director to lead safety evaluation and risk management across global programs, including pharmacovigilance activities in clinical development and post-marketing.

This remote role is based in Poland, with a 1-year contract and potential extension. Salary base 450,000 - 550,000 PLN gross per year. You will work across US/UK business hours and interact with regulatory agencies as needed.