Director Pharmacovigilance and Risk Management
Reporting to the VP Medical Affairs, the Director Pharmacovigilance and Risk Management has responsibility for leadership and oversight of the company’s pharmacovigilance and risk management activities across all products that are marketed and in development, including products subject to data safety agreements.
- Lead company pharmacovigilance and risk management strategies across all products marketed and in development.
- Oversee company pharmacovigilance activities including but not limited to data collection, monitoring, assessment, signal detection, evaluation, and tracking of safety information.
- Identifying, evaluating, and engaging pharmacovigilance vendor(s) and oversight of their activities and budget.
- Review adverse event (AE) reports, causality assessments and coding; assure timelines for reporting to regulatory authorities are met.
- Create and maintain project safety-related central files.
- Assure adverse events reported from external research projects (eg. IITs) are included in the product safety database.
- Create and oversee execution of Data Safety Exchange agreements.
- Work with Regulatory Affairs to coordinate regulatory safety submissions.
- Lead and coordinate Safety Review Committees and Signal Detection processes for both marketed and development products.
- Review study protocols and other documents as necessary for safety-related information.
- Work with Medical Directors/Safety Physicians, as needed, to consult on safety questions during medical monitoring activities.
- Maintain a high level of understanding of applicable Regulatory regulations (FDA and ICH guidance, GCP regulations; EU Directives, PVG Modules, etc.) to assist in ensuring all requirements are adhered to.
- Create and/or update company pharmacovigilance policies, SOPs and assure any required training of employees and vendors is completed.
- Observes all Trevena policies, SOPs and safety guidelines.
- Other duties as assigned.
EDUCATION & EXPERIENCE
- Minimum of a Bachelor’s degree in healthcare field (eg. nursing, life science or other equivalent); Advanced degree (PharmD, MD, PhD) a plus.
- At least five years of healthcare or pharmaceutical industry experience required.
- Extensive knowledge of pharmacovigilance regulation(s), ICH Good Clinical Practices. Knowledge of international pharmacovigilance regulations desirable.
- At least 5 years’ experience in pharmacovigilance, risk management and safety reporting in a pharmaceutical company.
KNOWLEDGE, SKILLS & ABILITIES
- Knowledge of clinical research and development including regulatory requirements.
- Knowledge of the role that their position plays in the Clinical Research Process.
- Team player: Effective proactive participant as a team member and team leader. Has participated positively in teams, supports goals and understands role. Is prepared to identify opportunities for improvement and communicates creative solutions.
- Strong Communication Skills: Understands and follows instructions efficiently and completely.
- Flexibility: Willing to change assignments and work focus to accommodate project demands.
- Detail orientated to a high degree for the accurate entry and processing of clinical data.
- Technology Proficiency: Able to use core MS Office products and proficient in safety database entry. Data Management Systems: Entry of Data, data processing, query identification.
- Good understanding of departmental and company procedures which relate to tasks that are performed routinely. Can communicate the key task, responsibility and documentation requirements for tasks performed routinely. Is able to identify other procedures as appropriate to the activity being undertaken.
Up to 20% domestic/international travel.
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