Purdue Pharma Hiring For Associate Medical Director, Safety Lead at Stamford, CT  Full Time

Associate Medical Director, Safety Lead

201 Tresser Blvd, Stamford, CT 06901, USA
Req #202

Friday, April 7, 2023

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.

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: IntegrityandCourage, underpinned byInnovation, and always inCollaborationwith 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!

We respect diversity and accordingly are an equal opportunity and an affirmative action 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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EMPLOYER: Purdue Pharma L.P.

TITLE: Associate Medical Director, Safety Lead

LOCATION: One Stamford Forum, 201 Tresser Blvd., Stamford, CT 06901

DUTIES:

Serve as the safety lead expert for all assigned products, including post-marketed and Class One drugs. Accountable for the overall safety profile, which includes pharmacovigilance, signal surveillance, and risk management activities for assigned products (investigational and marketed). Lead safety review team meetings and plays a critical leadership role in cross functional and external collaboration. Responsible for all safety data throughout the life cycle for assigned products. Maintain and provide therapeutic area knowledge and relevant safety evaluation of therapeutic area, including clinical trials, scientific literature, and non-clinical studies, and therapies for ongoing surveillance and signal detection. Lead safety signal surveillance and aggregate data analysis on an ongoing basis. Mentor and support Safety Scientists on assigned tasks. Lead the development of safety related documents such as safety monitoring plans, risk-assessments, and ad-hoc requests. Prepare responses to regulatory agency ad hoc queries and comments. 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. Position is based in Stamford, CT, but remote work is permitted. Candidate must be willing to travel to Stamford, CT office quarterly for in-person meetings as well as for any inspections or audits.

Doctor of Medicine (M.D. degree) and 5 years of experience in the job offered or related. Must have 5 years of experience with drug safety, clinical development, and medical safety. Must have 3 years of experience with Argus Safety Database. Must have 2 years of experience with: medical safety analysis and preparation of aggregate reports; medical review of marketed, post-marketed and clinical cases; and CRO oversight and vendor management and working with safety or clinical vendors. Must have experience with FDA and MHRA audits; and NDA filings.

TO APPLY:

[email protected] and reference code 18595.00072.

• 201 Tresser Blvd, Stamford, CT 06901, USA