Associate Director, Clinical Safety & Pharmacovigilance

Harmony Biosciences LLC • Plymouth Meeting, PA

7h • Hybrid

About The Position

Harmony Biosciences is recruiting for an Associate Director, Clinical Safety & Pharmacovigilance in our Plymouth Meeting, PA location. In this role you will be responsible for the operational oversight of pharmacovigilance related to Harmony Biosciences investigational and marketed products. This role is responsible for engaging with a team that performs pharmacovigilance services as well as working cross-functionally to support any risk-management activities. This role will ensure compliance with all company policies and applicable regulatory requirements.

Requirements

• Bachelor’s degree required
• 7+ years of Drug Safety/Pharmacovigilance experience in a pharmaceutical company with at least 5+ years’ experience with case processing, narrative writing, aggregate reporting, signal detection, signal evaluation, and risk management.
• Experience managing investigational and postmarketing pharmacovigilance activities required
• Detailed knowledge and experience using a global drug safety database (e.g., ARGUS) and medical terminology and drug product dictionaries (e.g., MedDRA, WHODrug).
• Detailed knowledge of current US and global pharmacovigilance regulations, guidance, and practice standards.
• Experience in managing external pharmacovigilance service providers.
• Experience supervising PV activities performed by clinical trial CROs.
• An understanding of the drug development process, including clinical trial methodology and GCPs; ability to comprehend clinical study reports and interpret scientific data.
• Strong verbal and written communication skills with the ability to communicate with colleagues, business partners, stakeholders and upper management across varied styles and cultures.
• Strong computer skills including proficiency in the use of Microsoft Office Suite.

Nice To Haves

• Advanced degree in health-care discipline strongly preferred
• Experience with FDA PADE inspections and Clinical PV audit readiness preferred.

Responsibilities

• Develop and maintain relevant standard operating procedures and working practice documents related to the processing and reporting of individual case safety reports.
• Implement and provide ongoing oversight of the services provided by the PV vendor.
• Collaborate closely with the company Medical Directors in the assessment and medical review of serious adverse events reported with investigational and marketed products.
• Collaborate with pharmacovigilance vendor(s) and internal stakeholders in the development, review, and approval of aggregate reports (e.g., PADER, DSUR, CSR).
• Exchange safety data with global business partners in accordance with Safety Data Exchange Agreements.
• Organize and participate in all aspects of cross-functional Safety Review Committee (SRC) meetings.
• Develop and deliver adverse event and product complaint training for company employees and external service provider personnel.
• Provide ongoing oversight of the services provided by Contract Research Organizations (CRO) vendors conducting company-sponsored clinical trials.
• Develop and maintain Safety Management Plans (SMPs) for planned and ongoing company-sponsored clinical trials.
• Perform ongoing serious adverse event reconciliation and coding reviews for company-sponsored clinical trials.
• Participate in investigator meetings to train investigators and site personnel in the collection and reporting of adverse events.
• Work cross functionally to ensure inspection readiness; serve as subject matter expert during regulatory inspections.
• Interface with internal stakeholders including Clinical Operations, Clinical Development, Regulatory Affairs, Medical Affairs, Legal, and Quality Assurance.
• Represent Clinical PV in cross-functional study team and program team meetings and interactions.
• Contribute to and review scope of work and budget for Clinical PV services.
• Comply with all Corporate Policies, business rules, and contractual agreements as set out and communicated by the company pursuant to good business practice.
• Comply with all regulations and guidance relevant to Good Pharmacovigilance Practices, postmarketing safety reporting, and IND safety reporting.
• Perform other duties as assigned by management.

Benefits

• Medical, Vision and Dental benefits the first of the month following start date
• Generous paid time off and Company designated Holidays
• Company paid Disability benefits and Life Insurance coverage
• 401(k) Retirement Savings Plan
• Paid Parental leave
• Employee Stock Purchase Plan (ESPP)
• Company sponsored wellness programs
• Professional development initiatives and continuous learning opportunities
• A certified Great Place to Work® for eight consecutive years based on our positive, values-based company culture

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees