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

Alphanumeric Systems; Polska; Teletrabalho; PLN 563 000 - 688 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Internet allowance €50

Remote work from home

Resumo da oferta

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 portfolio. The role covers development and post‑marketing safety, with emphasis on independent analysis, regulatory interactions, and cross‑functional governance.

The ideal candidate has strong clinical development and pharmacovigilance expertise, excellent scientific writing, and fluency in English.

Qualificações

• Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions.
• Experience responding to Health Authority RFIs.
• Strong understanding of benefit-risk assessment and safety evaluation.
• Experience supporting regulatory submissions and regulatory authority interactions.
• Excellent scientific writing and communication skills. Proficiency in English is mandatory.
• Ability to work independently in a fast-paced, highly matrixed environment.

Responsabilidades

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

Conhecimentos

Clinical development

Pharmacovigilance

Safety evaluation

Regulatory submissions

Scientific writing

English proficiency

Descrição da oferta de emprego

Alphanumeric is hiring a SERM Medical Director (Remote, 1-Year Contract with possibility of extension) to work for one of the biggest pharmaceutical companies in the world.

We are looking for a SERM Medical Director to support a global pharmaceutical organization's Safety Evaluation & Risk Management function. This role will provide medical leadership for the safety evaluation, benefit-risk assessment, and risk management of products in clinical development and post-marketing settings.

The ideal candidate will combine strong clinical development and pharmacovigilance expertise with the ability to independently assess safety issues, support regulatory interactions, and contribute to cross-functional decision‑making.

Location

Remote, based in Poland

Employment Type and conditions

Full-Time | 1-Year Contract | Potential Extension

Compensation and Benefits

• 625.000 PLN + Internet allowance up to 50€ gross + Health insurance for the worker
• Model: 100% from home.

Working Hours

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

Key Responsibilities

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

Required Qualifications

• Significant experience in clinical development, drug safety, pharmacovigilance, or related pharmaceutical functions.
• Experience responding to Health Authority RFIs.
• Strong understanding of benefit-risk assessment and safety evaluation.
• Experience supporting regulatory submissions and regulatory authority interactions.
• Excellent scientific writing and communication skills. Proficiency in English is mandatory.
• Ability to work independently in a fast-paced, highly matrixed environment.

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.