- Leads and/or oversees the signal detection and management (i.e., routine signal detection reports, tracking, review meetings, signal assessments, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing PV activities.
- Coordinates, contributes, and presents at safety governance meetings (e.g. Safety Management Teams, Executive Safety Committee, Signal Management and Review Team Meetings, etc.).
- Filing and maintaining GVP documentation including meeting minutes and materials for appropriate GXP recordkeeping activities and filing responsibilities.
- Authors and/or oversees the authoring of aggregate reports (i.e., DSUR, PBRER, PADER, etc.) for assigned product(s).
- Supports process improvement initiatives, inspection readiness activities and participates in inspection or audit related activities for assigned product(s) and/or MRM responsibilities.
- Coordinates with international and cross-functional teams responsible for collaborating on safety decisions for assigned product(s) in development and post-approval.
- Contributes to and/or reviews documents related to clinical trial safety, post-marketing safety, regulatory submissions, and labeling.
- Medical Science qualifications: Medical Degree, Pharmacy degree, Nursing degree (BS, MS), or MS in health-related field.
- At least 10 years of biotech/pharmaceutical industry experience, including at least 8+ years of experience in drug safety serving as a PV Scientist or similar role. Relevant experience in the Gastrointestinal therapeutic and/or rare disease area a plus. Experience collaborating with global business partners and/or vendors a plus.
- Experience with MedDRA coding, safety databases, and clinical trial databases.
- Experience with leading the development, authorship, and review of aggregate reports and/or key safety-related documents (i.e., DSUR, IND annual report, PBRER, PADER, RMPs, REMS).
- In depth knowledge of global post-marketing and clinical trial safety regulations, guidances, and reporting processes. Experience with a post-marketed product with ongoing clinical development a plus.
- Ability to recognize opportunities and/or issues and apply analytical and creative thinking to maximize performance.
- Ability to focus on delivering excellent results and improving the performance of oneself and of Ironwood by taking initiative to try new approaches, while still following the rules (e.g., company, government and ethical), by taking action to surpass one's own past performance, excel at an objective measure or goal, or do something that has never been done before.
- Ability to leverage a deep understanding of oneself through knowing one's strengths and weaknesses, proactively asking for feedback to balance self-perception, and being resilient in order to increase one's effectiveness.
- Ability to work cooperatively with colleagues and take initiatives to build relationships despite differences in interest, offering support and help to peers without being asked or proactively seeking input from others to solve problems.
- Ability to successfully lead, mentor, and manage a team of colleagues and/or direct reports.
- Excellent verbal and written communication skills with the ability to present complex information effectively.
- Strong organizational skills with the ability to re-prioritize and adapt to a fast moving environment.
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Director, Pharmacovigilance - Boston, MA, United States - Ironwood Pharmaceuticals
Description
Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.
Position Summary:
The Director of Pharmacovigilance (DPV) leads and/or oversees safety and benefit-risk management for assigned product(s), management of potential safety issues, identification of signals and their evaluation, and other activities such as drafting responses to regulatory inquiries on product safety issues for assigned product(s). The DPV works closely with the Global Safety Physician (GSP) and other colleagues within the Medical Risk Management (MRM) team for all deliverables related to benefit-risk management of assigned product(s). The DPV serves as a subject matter expert for MRM and cross-functional teams on product specific safety information, data output and analyses, and relevant global safety regulations and guidelines. In collaboration with the GSP, the DPV will have the following specific responsibilities:
Qualifications:
Competencies:
Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.
Ironwood currently anticipates that the initial base salary for this position could range from between $197,000 to $229,320. The actual base salary will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.
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