This role involves leading and supporting pharmacovigilance initiatives throughout clinical development, ensuring patient safety and compliance with international regulations. As a Safety Scientist, you will conduct safety surveillance by evaluating safety listings and interpreting complex medical data to identify potential risks.
Key Responsibilities
- Perform ongoing safety monitoring for assigned projects, including analysis of safety reports and data interpretation.
- Support the development of aggregate safety reports by coordinating data collection, managing queries, and collaborating with internal teams and external partners.
- Maintain and update plans for aggregate reporting, and contribute to the drafting or review of safety documentation, including sponsor-generated materials where applicable.
- Coordinate signal detection processes, from defining strategies to organizing source data and reviewing interval and cumulative findings according to established surveillance plans.
- Prepare or evaluate reports related to signal validation and assessment, and facilitate internal and external discussions on signal management.
- Review and draft safety content for key documents such as Investigator Brochures, reference safety information, and country-specific labeling.
- Assist in the creation and maintenance of Risk Management Plans (RMPs, dRMPs) and REMS, including data gathering, document coordination, and stakeholder collaboration.
- Monitor submissions related to risk management and support the rollout of risk minimization strategies.
- Lead literature search initiatives, from planning and defining search criteria to conducting searches and reviewing relevant scientific publications.
- Support the design and validation of patient safety systems and tools.
- Provide pharmacovigilance expertise during client meetings and cross-functional discussions.
- Help maintain essential pharmacovigilance records, including Pharmacovigilance System Master Files and service agreements.
- Track performance indicators and compliance metrics to support quality and efficiency.
- Assist in audit readiness activities and regulatory inspection preparations.
- Contribute to process improvements by developing and updating standard operating procedures, templates, and best practices.
- Support the implementation of new safety databases, systems, and digital tools.
- Participate in training initiatives, delivering pharmacovigilance education to staff, investigators, and clients.
- Stay current with evolving regulatory expectations, clinical research standards, and lifecycle safety requirements.
- Act as a Local or Qualified Person for Pharmacovigilance when required by project needs.
Qualifications
Candidates should hold a bachelor’s degree in pharmacy, life sciences, or a related field, with at least two years of experience in pharmacovigilance or drug safety within the pharmaceutical or clinical research sector. A solid grasp of global safety regulations and pharmacovigilance frameworks is essential. Strong analytical abilities, attention to detail, and effective communication skills are required to manage multiple priorities in a fast-paced environment.
An advanced degree is preferred. Prior experience in literature surveillance, safety reporting, signal management, or risk mitigation activities is highly valued.
Work Environment
This is a remote position available to candidates residing in Poland, Bulgaria, or Romania. The role supports a flexible work model aligned with local country requirements.
Benefits
The position offers a competitive salary and comprehensive benefits package tailored to regional needs. This includes flexible annual leave, health insurance options for employees and families, retirement planning support, and access to a global Employee Assistance Programme through TELUS Health. Additional country-specific benefits may include childcare subsidies, gym discounts, travel allowances, and wellness incentives. The organization emphasizes work-life balance and long-term well-being for employees and their families.
Company Culture
The company fosters an inclusive, high-performing environment where diversity and innovation are central to success. It is committed to nurturing talent, promoting belonging, and maintaining a workplace free from discrimination and harassment. Sustainability and community engagement are integral to its values, with ongoing efforts to operate responsibly and support the regions where teams live and work.
Equal Opportunity
All qualified applicants are considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. The organization upholds a standard of fairness and respect, ensuring a professional environment free from discrimination and harassment.
