Medical Director – M-SERM

This is a fully remote position, open to applicants in Colombia, +4 more countries.

📋 Description

• Maintain a comprehensive understanding of methods for documenting project and administrative time, submitting expenses, and managing travel logistics.

• Ensure that assigned Pharmacovigilance tasks are executed correctly and comply with relevant regulations, ICH guidelines, client directives, project WPDs, as well as CRG policies and SOPs/WPDs.

• Offer medical consultation to team members and address project- and study-related medical inquiries.

• Communicate with colleagues and clients to ensure adherence to proper procedures.

• Provide training on safety reporting for assigned projects and studies as needed.

• Conduct medical reviews of adverse-event and serious-adverse-event data from solicited, spontaneous, literature, and other sources.

• Review adverse events of special interest, serious adverse events, and clinical outcome events reported during clinical trials.

• Carry out contract-defined data review and validation, including coding listings and comprehensive safety data, to identify potential safety issues.

• Assist in writing and/or reviewing CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules, and related safety documentation.

• Oversee signal detection activities and conduct scientific reviews of periodic safety reports.

• Contribute to label updates, dossier maintenance, and risk management activities.

• Mentor and train entry-level Pharmacovigilance staff while liaising with CRG groups and clients.

⛳️ Requirements

• MD or equivalent degree required.

• At least one of the following: clinical experience with direct responsibility for diagnostic and treatment decisions equivalent to 2 years, or direct experience in medical review and assessment of safety information/Pharmacovigilance equivalent to 3 years.

• Fluent in both spoken and written English.

• General medical knowledge encompassing diagnostic and therapeutic approaches across various specialties.

• Working knowledge of FDA, ICH, EMA, and GCP guidelines.

• Understanding of basic biostatistics, data management, and clinical operations procedures.

• Familiarity with the drug development process and guidelines for marketing authorization submissions and international clinical studies.

• Knowledge of clinical program and study design, relevant endpoints, safety considerations, and the regulatory and commercial landscape.

• Understanding of pharmacovigilance regulations for marketed products.

• Proficiency with Drug Safety Dictionaries such as MedDRA.

• Experience with safety databases like ARGUS and ARISg.

• Capability to mentor and train entry-level Pharmacovigilance staff.

• Willingness to travel domestically and internationally.

• Proficiency in basic computer applications.

• Strong decision-making, problem-solving, organizational, analytical, communication, and interpersonal skills.

• A history of holding an active medical license is highly preferred.

🏝️ Benefits

• Fully remote work arrangement.

• Flexibility to travel domestically and internationally.

• Reasonable accommodation for individuals with disabilities during the application, interview, and employment process.