Exec Dir./ Dir of Pharmacovigilance - drug safety
(12 month contract to hire - REMOTE)
As the Executive Director/Director of Pharmacovigilance, Drug Safety at [Company Name], you will play a pivotal role in ensuring the safety and efficacy of our pharmaceutical products. With your medical doctorate degree, you will lead our efforts in pharmacovigilance, risk management, and benefit-risk assessment.
Medical Expertise: Utilize your medical doctorate degree to provide medical leadership and guidance for the Pharmacovigilance department.
Experience Requirement: Bring a minimum of 5+ years of relevant experience in pharmacovigilance and drug safety.
Regulatory Compliance: Ensure adherence to regulatory requirements and guidelines, including but not limited to Module 274, risk management plans, qualitative and quantitative methodologies, and adverse drug reactions (ADRs).
Signal Detection: Demonstrate a deep understanding of signal detection methodologies to proactively identify potential safety concerns.
Post-Marketing Surveillance: Oversee post-marketing safety surveillance activities and drive continuous improvement in post-marketing safety assessment.
Benefit-Risk Assessment: Lead and contribute to benefit-risk assessments for our pharmaceutical products, ensuring that the benefits to patients far outweigh the risks.
Cross-Functional Collaboration: Collaborate with cross-functional teams to integrate pharmacovigilance strategies into product development, clinical trials, and regulatory submissions.
Team Leadership: Manage and mentor a team of professionals within the Pharmacovigilance department, fostering their growth and development.
Compliance and Quality: Ensure high standards of quality and compliance in all pharmacovigilance activities, including the preparation of safety reports and documentation.
Medical doctorate degree (M.D.) with a strong focus on pharmacovigilance, drug safety, or related field.
Minimum of 5+ years of experience in pharmacovigilance, risk management, and benefit-risk assessment.
In-depth knowledge of regulatory guidelines and requirements, including Module 274.
Proficiency in qualitative and quantitative methodologies for pharmacovigilance.
Strong understanding of adverse drug reactions (ADRs) and their assessment.
Expertise in signal detection and its application in the pharmaceutical industry.
Experience in post-marketing surveillance and benefit-risk assessment.
Excellent leadership, communication, and organizational skills.