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Associate Medical Director, Safety Lead

Stamford, CT, USA Req #115
Tuesday, March 29, 2022

Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications and consumer health products 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.


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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 dayWe welcome the opportunity to have you on our team!

 

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Job Summary: 

The Drug Safety & Pharmacovigilance (DSP) Safety Lead, will serve as the safety expert for assigned products. The DSP Safety lead will be accountable for the overall safety profile, which includes pharmacovigilance, signal surveillance, and risk management activities, for assigned products (investigational and marketed); leads Safety Review Team meetings and plays a critical leadership role in cross-functional and external collaboration. Using medical and pharmacovigilance expertise, the position supports the Executive Medical Director, Medical Safety, in ensuring continued surveillance and safety risk management of company products.

 

Primary Responsibilities: 

  • Responsible for all safety data throughout the life cycle for assigned product(s)
  • Maintain and provide therapeutic area knowledge and relevant safety evaluation of therapeutic area (including but limited to clinical trials, scientific literature, and non-clinical studies) and therapies for on-going surveillance and signal detection.
  • Lead safety signal surveillance, and aggregate data analysis on an ongoing basis
  • Provide benefit-risk assessment on potential safety signal or in safety documents (e.g signal report, clinical overview, etc) leading to development or update of product labels (e.g CCSI, USPI, etc..) as needed
  • Work with the PV leadership team, to develop the strategy and implementation of safety and benefit-risk management
  • Responsible for key safety content in safety aggregate reports (e.g PBRERs, periodic line listings, NDA safety updates, etc...), and Risk Management documents (e.g RMPs, REMS)
  • Review and contribute to safety sections within clinical documents such as, Investigator’s Brochure, Reference Safety Information, Study Protocol, Informed Consent Forms and DSURs,
  • Lead and/or contribute to the development of safety related documents such as safety monitoring plans, risk-assessments, and ad-hoc requests, etc.
  • Lead cross-functional safety review team meetings and collaborate with team members to ensure patient safety for assigned products
  • Support and collaborate with cross-functional teams on safety related activities including AE/SAE reviews, reconciliation, preparing and presenting safety data at meetings, providing responses to health authority requests
  • Mentor and support the Safety Scientists on assigned tasks
  • Collaborate effectively with key stakeholders, including business partners and vendors, and ensure they are informed of evolving safety issues and strategies
  • Support and contribute to the development of Pharmacovigilance Agreements as needed
  • Participate in the development of pharmacovigilance plans / development Risk Management Plans (DRMP) for marketed / investigational products
  • Prepare responses to regulatory agency ad hoc queries and comments
  • Provide expert input on business development opportunities
  • Experience in responding to inquiries from Regulatory agencies
  • Working knowledge of Risk Management and Mitigation Strategy (REMS)

 

Education and Experience:

  • A Medical Degree (MD or equivalent) is required
  • A doctoral degree and/or MPH is desirable
  • Minimum 5 years of relevant experience in drug safety, clinical development and/or medical affairs, within the biotechnology or pharmaceutical industry is required
  • Experience in data analysis and aggregate reporting is desirable

Necessary Knowledge, Skills and Abilities:

  • Understanding of the drug development process
  • Advanced understanding of regulations and FDA, ICH, and GVP guidance
  • Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product
  • Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research
  • Understanding of regulatory requirements for safety assessment and action
  • Strong scientific analytical reasoning skills
  • Efficient time management and ability to prioritize workload
  • Advanced project management skills
  • Ability to work on multiple complex projects in parallel
  • Excellent attention to detail
  • Behavioral competencies necessary to work and lead within a complex matrix environment
  • Ability to influence others
  • Ability to work without appreciable direction toward long-range goals and objectives
  • Solid computer skills and understanding of Safety Databases
  • Excellent verbal and written communication skills

 

Supervisory Responsibilities (if applicable):

N/A

 

 

Job Titles Supervised:

N/A

Other details

  • Job Family Medical Affairs
  • Pay Type Salary
Location on Google Maps
  • Stamford, CT, USA