The Forest Research Institute (FRI) a wholly-owned subsidiary of Forest Laboratories, Inc. drives the scientific research and development behind Forest's top-quality therapies that help people lead healthier, more fulfilling lives. With operations in Jersey City, NJ and on Long Island, plus clinical trial personnel across the country, the Institute's highly skilled professionals enable Forest to license compounds at virtually any stage-from preclinical development to products that are ready for FDA review, and then complete the development and regulatory work to successfully bring vital new therapies to market. Each of Forest's more than 5,000 employees, including our 1,000 person strong Research Institute, contributes to our quest to deliver quality products with entrepreneurial spirit, integrity and deep respect for people and community. Explore your potential to thrive with a career at Forest.
Our Jersey City,NJ office has an exciting opportunity available in Global Drug Safety for a Senior Scientist, Safety Information Management.
Duties and Responsibilities
-The Senior Scientist in PVRM Safety Information Management group is responsible for safety surveillance documentation, archiving, and preparation of aggregate safety reports of the company products.
-Contribute to safety Management Team (SaMT) meetings (internal or with partner companies).
-Author associated supporting safety documentation for SaMT.
-Summarize highly complex safety data from clinical studies and post-marketing, and writes and prepares safety regulatory documents and submissions, including complex stand-alone documents and submissions.
-Author aggregate safety reports including ASRs and future DSUR.
-Author responses to regulatory agency safety enquiries.
-Collaborate with product safety physicians to compile safety data for presentation at internal, external and professional meetings.
-Work effectively both independently and within a team and collaborates cross-functionally when required.
-Critically review documents produced for scientific content and alignment with company position, clarity, accuracy, and consistency.
-Chair round table meetings in order to produce reports with consensus of all concerned with respect to scientific standards and regulatory authorities.
-Assist in the development of formats and guidelines for safety documentation.
-Assist in the facilitation of document review meetings and discussions.
-Ensure that the afore-mentioned reports and plans become available within strict timelines and according to the required regulatory quality standards.
-Prepare internal guidelines for safety document preparation.
-Prepare templates for safety documents that are consistent with FDA and ICH guidelines.
MSN/BPharm/PharmD is a plus
Minimum 5 years in aggregate safety reporting across all safety regulatory documents (e.g., IND annual safety report, ASR, DSUR, PSURs, and PADERs).
Knowledge, Skills, and Abilities
Understanding/knowledge of the following areas:
FDA, EU, and ICH guidelines and regulations
Pharmacovigilance and Risk Management
Clinical Trials, Drug Development
Coding dictionaries (e.g., WHO ATC drug dictionary, and MedDRA)
Drug safety database knowledge: ARISg and DS Explorer (data mining software tool) experience and navigation skills preferred
Proficiency with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat Professional
Familiarity with Microsoft Visio and Microsoft Project is a plus
Experience with Business Objects (BOXI) is a plus
Ability to work with templates
Must possess excellent skill/ability in the following:
Oral and Written Communication
Planning and Organizing
Decision Making, Judgment, and Problem Solving
People Relationships and Team Building
Initiative and Accountability
Promoting Innovation and Process Improvement
Mentoring is a plus
Strong presenting skills
Good team player
Ability to work to tight timelines while maintaining accuracy
Ability to summarize complex data and identify relationships
Attention to accuracy and a flexible attitude
Ability to work proactively with minimal supervision
Forest offers generous compensation packages; comprehensive training programs; stock options, profit sharing and 401(k) company match; excellent benefits packages; and a supportive work environment that thrives on teamwork and a commitment to excellence.
Committed to continuing diversity at work.
Please apply directly to our company website through the following link:
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Thank you for your support and interest in Forest Laboratories Inc. It is our practice to recruit and fill career opportunities through the Human Resources, Talent Acquisition organization. We ask that you not submit candidates for consideration to us without receiving a formal written request from the Talent Acquisition organization to do so. All resumes submitted; (with or without use of your agency access credentials) will be deemed unsolicited and as such will not be eligible for placement fees. We look forward to working with you and appreciate your cooperation.
Forest Laboratories doesn't just blend in with the trees. The company develops and manufactures prescription drugs to address a wide...