Associate Medical Safety Director – Sponsor Dedicated

This is a fully remote position, open to applicants in Romania.

📋 Description

• Engage in all facets of Medical Safety activities as per the defined scope of work.

• Offer and uphold pharmacovigilance and risk management expertise for both internal and external stakeholders.

• Keep abreast of knowledge pertinent to assigned product portfolios.

• Perform medical evaluations of post-marketing adverse drug reactions.

• Review and contribute to signal management and benefit-risk assessments for drugs in clinical trial and post-marketing scenarios.

• Prepare and/or assist in formulating responses to inquiries from health authorities.

• Examine and contribute to periodic aggregate reports.

• Aid in safety reviews of study protocols, investigator brochures, and other reference safety documentation.

• Act as an internal consultant providing medical support for pharmacovigilance operations.

• Deliver aggregate reviews of safety information, including clinical data, to maintain oversight of product safety profiles.

• Lead signal detection and analysis, which includes strategy development, frequency, and timing; review Signal Detection Reports and other data sources; propose potential signals for team discussion; and contribute to safety analysis reports and presentations.

• Provide medical review and input for IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, and US Periodic Reports.

• Offer medical review and contributions to Development Risk Management Plans, EU Risk Management Plans, and US Risk Evaluation and Mitigation Strategies.

• Review and participate in benefit-risk evaluations of medications.

• Provide safety oversight and contributions for the development, review, and updates of labels.

• Contribute medical safety insights to the Integrated Safety Summary or Common Technical Document.

• Conduct medical reviews and clarifications of trial-related adverse events and post-marketing adverse drug reactions, including narratives, queries, coding, expectedness, seriousness, causality, and company summaries.

• Serve as an internal consultant for pharmacovigilance case-processing teams.

• Present safety and clinical data review findings in meetings with internal and external stakeholders.

• Offer medical safety support, contributions, and participation in Safety Governance and other meetings as required.

⛳️ Requirements

• A medical degree from an accredited and internationally recognized medical institution.

• Approximately three years of clinical practice experience, in addition to two years in the pharmaceutical or related industry, or an equivalent combination of education, training, and necessary experience.

• Familiarity with relevant federal and local regulations and guidelines related to clinical research, safety, good clinical practice, clinical trials, and pharmaceutical research processes.

• Knowledge of the assigned product portfolio, therapeutic area, and current literature.

• Experience in signal detection, aggregate reports, and risk management.

• Ability to synthesize and critically evaluate data from various sources and articulate complex clinical issues and analyses both verbally and in writing.

• Capability to set and achieve priorities, deadlines, and objectives.

• Proven skills in managing multiple assignments; ability to work under pressure; demonstrate initiative, flexibility, and adaptability to changing business requirements.

• Ability to establish and maintain effective working relationships with colleagues, managers, and clients, including providing mentorship as necessary.

🏝️ Benefits

• Comprehensive health insurance coverage.

• Opportunities for professional development and continuing education.

• Flexible working hours and remote work options.

• Supportive work environment with a focus on collaboration and team success.