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

Alphanumeric Systems; Polska; Remote; 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. 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

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.