About the job Director, Pharmacovigilance MD
Job Title: Director, Pharmacovigilance MD
Job Location: Morrisville, NC, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level About KriyaKriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.We are proud to have been named Triangle Business Journal's Life Sciences 2024 Best Private Company to Work For and recognized by Forbes as one of America's Best Startup Employers of 2024 .Who You AreThe Director, Pharmacovigilance MD (Medical Doctor) serves as a critical medical and data analytical role for Kriya's investigational and/or marketed products. They are responsible for designing and developing product safety surveillance programs. This role involves clinical evaluation of adverse event reports, risk assessment, and collaboration with various stakeholders to ensure regulatory compliance and patient safety.How You Contribute
- Design and develop pharmacovigilance and safety strategies across asset portfolio. Lead presentations of sophisticated safety topics both internally and externally.
- Oversee clinical evaluations of adverse event (AE) reports, causality assessment and severity of the AE while providing medical expertise in the analysis and interpretation of AE data. Oversee the maintenance and updating of the PV database.
- Develop, recommend, and oversee implementation of risk management/mitigation plans for pharmaceutical product. Oversee preparation of and review safety narratives, case reports, and aggregate reports.
- Ensure compliance with local and international pharmacovigilance regulations (e.g., FDA, EMA, ICH). Oversee preparation and submission of periodic safety update reports (PSURs) and other regulatory documents. Liaise with regulatory authorities on safety-related matters.
- Monitor safety profiles of products through post-marketing surveillance and clinical trials.
- Collaborate with cross-functional teams, including clinical, regulatory, CMC and quality assurance to ensure completion of corrective and preventative actions.
Education ExperienceWhat You Bring to the Team
- Medical degree (MD) required. Valid US medical license.
- Additional certification in pharmacovigilance or drug safety is preferred.
- Minimum 5+ years of experience in pharmacovigilance or a related field.
- In-depth knowledge of pharmacovigilance regulations and guidelines.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Proficiency in pharmacovigilance databases and software.
Competencies
- Ability to critically evaluate clinical data.
- Strong understanding of drug development and lifecycle management.
- Detail-oriented with strong organizational skills.
- Ability to work independently and as part of a team.
- Proficiency in medical writing and documentation.
- Strong ethical standards and commitment to patient safety.
Working Conditions
- Primarily desk-based, generally in an office or home office setting.
- Involves extended periods of sitting and computer use.
Discover True Collaborative TeamworkWe have an ambitious set of goals, but our confidence - and our inspiration - stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.We're always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.What We OfferMedical, Dental and Vision • 401(k) with Company Match • Short and Long-term Disability Benefits • Company Paid Holidays • Flexible Time Off • Cyber Safety protection • EAP • Life Insurance •Equity •and more!Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested. Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.Please use the below Lifelancer link to Apply and view similar roles.