The Pharmacovigilance (PV) Safety Scientist /Senior Scientist is responsible for participating in the PV operational activities including but not limited to interfacing with designated vendors/CROs, participating in regulatory inspections, individual or aggregate review and reporting of safety data from various sources in support of regulatory aggregate reporting requirements and activities pertaining to our products.
This position reports to the Executive Director, Head of Pharmacovigilance, Drug Safety & PV and is located at our Bridgewater, New Jersey headquarters location.
Provide oversight of Insmed PV Safety operations and or designated CROs and Vendors, as assigned by the Head of Pharmacovigilance.
Maintain Quality metrics for PV CROs or Vendors.
Perform the source document Quality Check (QC) review of adverse event reports.
Responsible and oversight for PV inspection readiness activities and quality in collaboration to Insmed Quality Assurance.
Review and or Author high quality aggregate safety reports including DSUR, PBRER or PADER to meet regulatory and internal deadlines.
Ensure all safety regulatory documents are processed and submitted according to regulatory requirements and timelines.
Critically draft or review documents produced for regulatory agency safety inquiries in terms of scientific content and alignment with company position, clarity, accuracy, and consistency and facilitate document review by other contributors.
Participate in review of scientific literature and create literature summary sections.
Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
Assist designated safety vendors with opinion on obtaining follow-up information for individual cases and ensuring appropriate feedback from Global Clinical and Safety Leads.
Interface with other Insmed functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed.
Contribute to on-going process enhancement for safety operations such as developing standard procedures and templates.
Bachelors, Master’s or Doctorate level degree in pharmacy, nursing or other health care related profession or life sciences required.
Additional MPH (Masters of Public Health) or Masters in Business Administration (MBA) or Healthcare Administration is a plus
Minimum 5 years in Drug safety/Pharmacovigilance in pharmaceutical industry setting with both investigational and marketed products
Practical examples of end-to-end project management within Drug Safety/PV or relevant experience
Active participation in regulatory inspections is a plus
At least 1 years of experience with medical case reviews, aggregate safety reporting, safety surveillance, signal management and/or Risk management
Ability to review and or prepare, scientific or regulatory documents, from large volumes of scientific information
Knowledge and understanding of national & international PV and regulatory guidelines
Drug safety database knowledge preferred
Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat computer skills
Must have excellent communication skills (verbal and written).
Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
May require very occasional Domestic/International as needed (estimated at less than 10% of work time)
Must successfully exhibit Insmed’s five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies.
Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
Internal Number: n/a
About Insmed Incorporated
We are a publicly traded (NASDAQ: INSM) biopharmaceutical company dedicated to improving the lives of patients battling serious lung diseases. We are focused on the development and commercialization of novel, targeted inhaled therapies for patients with high unmet need battling orphan lung diseases.
Our lead product candidate, ARIKACE (liposomal amikacin for inhalation), is designed to treat rare lung infections in patients who have limited alternatives for treatment. ARIKACE is a differentiated, inhaled antibiotic engineered to deliver a proven and potent anti-infective directly to the site of serious lung infections to improve the efficacy, safety and convenience of treatment for patients.
Currently, we are continuing late-stage clinical trials for two initial primary target orphan indications for this product: lung infections caused by Pseudomonas in CF patients and lung infections caused by NTM. We expect to report clinical results from both clinical trials in 2013. Our sole development focus is to obtain regulatory approval for ARIKACE and to prepare for its commercialization in the US, Canada and Europe.