Safety Physician

Precision For Medicine; Warszawa; On-site; PLN 340,000 - 511,000; Full time

Benefits offered by this job

Discretionary annual bonus

Private medical insurance

MultiSport Card

Life insurance

Pension

Home working allowance

Vacation

Job summary

Precision for Medicine is hiring an experienced Drug Safety Physician to oversee pharmacovigilance, medical review, and safety reporting across global regulatory requirements. The role supports risk management and safety data analysis, with collaboration across CROs and internal teams, including DSMB leadership.

Candidates with oncology safety experience and strong regulatory interactions are preferred. The position may be based in various countries including Poland, with travel under 20%.

Qualifications

• MD degree with 7+ years in drug safety activities.
• Experience in oncology safety and early development.
• Experience authoring and reviewing regulatory drug-safety reports.
• Regulatory interactions or inspections experience.
• Strong knowledge of FDA, EU, ICH safety requirements.
• Proficient with safety databases and MS Office.
• Ability to work with cross-functional teams under tight timelines.
• Less than 20% travel.

Responsibilities

• Oversee pharmacovigilance and safety data review, risk communication and signal detection.
• Provide medical safety expertise for benefit-risk assessment and SAE reviews.
• Collaborate with CROs and internal teams on safety monitoring and reporting.
• Input safety sections in protocols, reports and regulatory responses.
• Lead DSMBs and safety data review meetings.
• Support safety data management and regulatory compliance across territories.

Skills

Medical review

Pharmacovigilance leadership

Risk assessment

Safety reporting

Medical communication

Education

MD degree

7+ years in Drug Safety

Tools

ARGUS

Safety databases

Job description

Precision for Medicine is hiring an experienced Drug Safety Physician to join our team. Candidates can be based in the UK, Hungary, Poland, Romania, Serbia or Slovakia.

Position Summary

The Drug Safety Physician will be responsible for the pharmacovigilance function, including medical review and oversight of processing for all types of safety events. The individual will provide clinical support of drug safety data management and interpretation and risk management activities for the company, including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation. This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs).

Responsibilities (including But Not Limited To)

• Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
• Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of SAEs
• Work with CRO Safety Physicians/Team and Dragonfly’s Medical Directors, Clinical Scientists and other functions on safety monitoring, assessment and reporting activities (case and aggregate)
• Input on safety sections in cross-functional documents (eg, study protocols, study reports, IBs, ICFs) and on responses to safety-related questions from regulatory agency, IRBs and Ethics Committees
• Act as the point of contact accountable for setting up and running DSMBs or safety data review meetings
• Participate in routine safety cohort reviews for ongoing Phase 1 dose escalation studies
• Perform event coding review and clinical & safety database reconciliation for consistent coding
• Oversee and manage Drug Safety system(s) to ensure compliance with safety data management and reporting requirements in all relevant territories and optimized safety database ownership and access for safety monitoring, signal detection and reporting
• Ensure effective SOPs and strong safety vendor governance are in place
• Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File
• Ensure audit and inspection readiness of the function at all times

Education And Skills Required

• MD required, with a minimum of 7 years in Drug Safety related activities in pharma/biotech
• Clinical trial experience, including oncology drug safety with least 3 years being in early clinical development
• Experience authoring, reviewing, and providing input to drug-safety related regulatory reports
• Successful involvement in regulatory agency interactions or inspections
• Strong knowledge of FDA, EU, ICH and other global regulatory requirements for safety reporting and safety data and risk management
• Solid medical knowledge and familiarity with medical concepts and terminology used in hematology/oncology clinical trials and safety monitoring
• Proficiency with using standard computer applications (eg Microsoft Office, Windows) and safety databases
• Possesses a sense of urgency and an ability to anticipate and respond quickly to emerging information
• Excellent oral and written communication skills for effectively interfacing with vendors and internal stakeholders
• Fosters strong relationships and values collaboration to develop and execute on plans
• Ability to multi-task in a fast-paced environment
• Self-motivated, conscientious, and enthusiastic about curing human diseases

Other Required

• Experience with case processing in ARGUS
• Experience of Analysis of Similar Events (AoSE) and patient safety narratives
• Demonstrated ability to challenge existing practices to become more effective.
• Ability to effectively adapt to a variety of situations.
• Meet quality and performance standards.
• Strong influencing skills
• Excellent communication skills, both written and oral
• Work effectively as a team member and promotes collaboration.
• Demonstrate ownership, initiative and accountability.
• Less than 20% travel.

Competencies

• Ability to deliver on commitments and understanding of service culture.
• Communicates effectively and efficiently on safety issues to internal and external stakeholders.
• Maintain consistency of safety assessments.
• Serve in cross-functional teams as Drug Safety expert.
• Monitor regulatory compliance of safety reporting throughout trial.
• Lead and contribute to process development and/or process improvements that support Drug Safety

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.

This role is also eligible for a discretionary annual bonus, private medical insurance, MultiSport Card, life insurance, pension, home working allowance, vacation, among other benefits.

Reasonable Estimate Of The Current Range For Poland

340,080 PLN - 511,200 PLN gross per annum

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail].