Senior Manager, Drug Safety Vendor Operations Position Available In Western Connecticut Planning Region, Connecticut

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 DSandP 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, and 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 and inspections 2-4x per year.

Salary:

$127,900 – $179,000/yr.

Job location: One Stamford Forum, 201 Tresser Blvd., Stamford, CT 06901.

Requirements:

Masters 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; and 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.