Scientific Director (SERM & Clinical Safety & Pharmacovigilance) - Remote - Based in Poland

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

About the role

Alphanumeric is seeking a SERM Scientific Director to support a global Safety Evaluation & Risk Management organization. This role is responsible for providing scientific leadership in the evaluation of product safety, benefit-risk management, and pharmacovigilance activities across clinical development and post-marketing programs.

The successful candidate will be a strong scientific leader capable of independently managing safety issues, supporting regulatory activities, and contributing to strategic safety decision-making across global programs.

Expertise in some of the following therapeutic areas are requested: Classic Established products, Oncology, Respiratory, Immunology, Inflammation, Vaccines and Infectious Disease.

Location

Remote, based in Poland.

Job Conditions

Full-Time | 1-Year Contract | Potential Extension

Model: 100% from home.

Salary base: between 450.000 - 550.000 PLN gross per year.

• Benefits: internet allowance up to 50€ gross per month + Health insurance for the worker.

Working Hours

Candidates must be available to work within U.S. and/or U.K. business time zones.

Key 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 Requests for Information (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

Required Qualifications

• Advanced scientific or healthcare-related 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 escalata issues when needed.
• Experience working effectively within global cross-functional teams

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.