Associate Director, Clinical Safety & Pharmacovigilance

Plymouth Meeting, PA, United States

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 activities 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. The incumbent will ensure compliance with all company policies and applicable regulatory requirements.

Responsibilities include but are not limited to:

Develop and maintain all 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 pharmacovigilance 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 and internal stakeholders in the development, review, and approval of aggregate reports (e.g., PADER, DSUR).

Develop and maintain Safety Data Exchange Agreements with global business partners.

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 vendors conducting company-sponsored clinical trials and pregnancy registry studies.

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 as needed.

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.

Qualifications:

Bachelor's degree required; Advanced degree in health-care discipline strongly preferred.

8+ 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.

Breadth and depth of experience managing investigational and postmarketing pharmacovigilance activities.

Detailed knowledge and experience using a global drug safety database (e.g., ARGUS) and medical terminology dictionary (e.g., MedDRA).

Detailed knowledge of current US and global pharmacovigilance regulations, guidance, and practice standards.

Experience with FDA PADE inspections and PV audit readiness preferred.

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.

Proficient in the use of Microsoft Office Suite

Physical demands and work environment:

Domestic travel is estimated to be no more than 5% of the time for this position.

While performing the duties of this job, the noise level in the work environment is usually quiet.

Manual dexterity required to use computers, tablets, and cell phone.

Occasionally required to sit for prolonged periods.

What can Harmony offer you?

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 six consecutive years based on our positive, values-based company culture

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Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com

Harmony Biosciences, LLC is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.