Sr. Manager, Drug Safety Vendor Operations

Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians, and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications through internal research & development and strategic industry partnerships.

For close to two decades Purdue has engaged in many initiatives to stem prescription opioid abuse. We are committed to bringing lifesaving relief to communities and individuals suffering from substance use disorder and overdose. We are currently developing or supporting the development of two essential life-saving opioid overdose reversal medications and have the capability to manufacture others for medication assisted treatment. Providing these medicines has the potential to improve and save countless lives.

We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.

We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to Purdue's Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other.

At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We strive to create an environment where you can bring your best to work each day. We welcome the opportunity to have you on our team!

Purdue Pharma L.P. seeks Senior Manager, Drug Safety Vendor Operations in Stamford, CT to help lead the Drug Safety Operations function and provide oversight of third-party pharmacovigilance providers. Drive and ensure compliance with relevant regulatory requirements; internal policies and procedures; and Pharmacovigilance (PVA) agreements. Oversee US adverse event case processing and ensure processes and procedures meet global safety reporting requirements and complaints with PVA agreements. Serve as internal and external representative for the US Drug Safety Operations department. Contribute to innovative ideas and implementation plans for further development and improvement of Drug Safety Operations processes and procedures. Play a key role in the development, implementation, and maintenance of standard operating procedures (SOPs), job aids, work instructions, training materials and other DS&P work procedures to ensure compliance with ICH guidelines and local regulatory requirements as well as ensure procedural details are applied and followed in operational DSP and outsourced activities. Review group quality, compliance and performance metrics. Provide operational support for generation of aggregate report schedule. Oversight of aggregate report preparation and timely submission of aggregate reports such as Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Periodic Benefit Risk Evaluation Report (PBRERs), Investigational New Drug (IND), and any other adhoc annual reports to ensure regulatory compliance. Represent Drug Safety Operations function and department on company-sponsored clinical trial operational teams. Author/review study protocols, safety study management plans, assist in clinical database setup and database reviews, support training of external vendors on AE reporting, & ensure procedures are in place for the timely and accurate reporting of clinical trial SAE reports into the safety database. Full-time telework permitted from CT, NJ, NY, NC, and MA. Travel to Purdue headquarters in Stamford, CT required for audits & inspections 2-4x per year.

Salary: $127,900 - $179,000/yr

Job location: One Stamford Forum, 201 Tresser Blvd., Stamford, CT 06901. Full-time telework permitted from CT, NJ, NY, NC, and MA.

Requirements: Master's degree with concentration in Healthcare, Health Care Management Life Sciences, or a directly related field and 2 years of experience in the job offered or a related drug safety occupation. Must have 2 years of experience in the following: Working within the pharmaceutical industry; Drug Safety and pharmacovigilance experience; Experience managing Pharmacovigilance third party vendors; Experience applying and understanding the applicable regulations and guidance from Food Drug Administration (FDA), International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH), and Good Pharmacovigilance Practices (GVP); Experience in labeling and therapeutic class; Experience in Safety Databases, including Argus Safety; & Experience utilizing MedDRA and WHO drug dictionaries to understand regulatory information for medical products.

To apply: Send resume to careers@pharma.com and reference code 18595.00073 (Senior Manager, Drug Safety Vendor Operations)

We are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.

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