Director, Pharmacovigilance

Found in: Jooble US O C2 - 2 weeks ago

Boston MA, United States Ironwood Pharmaceuticals Full time

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:

  • 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.

Qualifications:

  • 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.

Competencies:

  • 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.

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.

#LI-Hybrid

#J-18808-Ljbffr

  • Director, Pharmacovigilance Operations

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Tango Therapeutics Full time

    Company Overview Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at...

  • Senior Director, Drug Safety and Pharmacovigilance

    Found in: Jooble US O C2 - 1 week ago

    Boston, MA, United States The Elle Group Full time

    The Senior Director, Drug Safety and Pharmacovigilance is responsible for leading safety surveillance and ensuring compliance with legal and regulatory requirements for pharmacovigilance, signal management, and risk management. - MD degree and board certification preferred - First in Human-Post Marketing experience - 7+ years of experience as a safety...

  • Head of Pharmacovigilance Operations and Compliance

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Tango Therapeutics Full time

    Company Overview Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at...

  • Senior Director, Drug Safety and Pharmacovigilance

    1 week ago

    Boston, United States The Elle Group Full time

    The Senior Director, Drug Safety and Pharmacovigilance is responsible for leading safety surveillance and ensuring compliance with legal and regulatory requirements for pharmacovigilance, signal management, and risk management. - MD degree and board certification preferred - First in Human-Post Marketing experience - 7+ years of experience as a safety...

  • Senior Director, Drug Safety and Pharmacovigilance

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Boston, United States The Elle Group Full time

    The Senior Director, Drug Safety and Pharmacovigilance is responsible for leading safety surveillance and ensuring compliance with legal and regulatory requirements for pharmacovigilance, signal management, and risk management. - MD degree and board certification preferred - First in Human-Post Marketing experience - 7+ years of experience as a safety...

  • Senior Director, Drug Safety and Pharmacovigilance

    Found in: Jooble US O C2 - 2 weeks ago

    Waltham, MA, United States Dyne Tx Full time

    Senior Director, Drug Safety and Pharmacovigilance With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitations in delivery to muscle tissue.Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonicdystrophy type 1 (DM1) and Duchenne muscular...

  • Senior Director, Pharmacovigilance and Vaccine Safety

    Found in: Appcast US C2 - 6 days ago

    Boston, United States HireMinds Full time

    Director/Sr. Director, Pharmacovigilance, Vaccine SafetyBoston, MAOur client is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The ideal candidate for this role will oversee signal and PV life-cycle management and will be involved in a broad variety of PV and clinical safety activities.This is a full-time...

  • Senior Director, Pharmacovigilance and Vaccine Safety

    Found in: Appcast Linkedin GBL C2 - 5 days ago

    Boston, United States HireMinds Full time

    Director/Sr. Director, Pharmacovigilance, Vaccine SafetyBoston, MAOur client is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The ideal candidate for this role will oversee signal and PV life-cycle management and will be involved in a broad variety of PV and clinical safety activities.This is a full-time...

  • Senior Director, Drug Safety and Pharmacovigilance

    Found in: Jooble US O C2 - 2 weeks ago

    Waltham, MA, United States Dyne Tx Full time

    Our commitment to people with muscle diseases is our greatest strength Senior Director, Drug Safety and Pharmacovigilance Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing...

  • Business Development Director

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Prime Vigilance Ltd Full time

    We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality...

  • Business Development Director

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Prime Vigilance Ltd Full time

    We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and...

  • Business Development Director

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States PrimeVigilance Full time

    Job Description Job Description Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical...

  • VP, Drug Safety

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Meet Full time

    An exciting opportunity with a pioneering pharmaceutical company dedicated to advancing healthcare through innovative drug development within Neurology. With a focus on breakthrough therapies, striving to improve the lives of patients worldwide. Position Overview: This innovative organization is looking to bring on a highly experienced and dynamic VP,...

  • Senior Medical Director, Drug Safety

    4 days ago

    Boston, United States Klein Hersh Full time

    Reporting to the Head of Global PV & Risk Management, the Senior Medical Director will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician is expected to provide interpretation and summaries of drug safety information...

  • Business Development Director

    1 week ago

    Boston, United States Ergomed Full time

    Company DescriptionWe are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...

  • Senior Medical Director, Drug Safety

    6 days ago

    Boston, United States Klein Hersh Full time

    Reporting to the Head of Global PV & Risk Management, the Senior Medical Director will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician is expected to provide interpretation and summaries of drug safety information...

  • Business Development Director

    1 week ago

    Boston, United States PrimeVigilance Full time

    Job Description Job Description Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical...

  • Director of IT, Clinical Development Systems

    Found in: Jooble US O C2 - 3 days ago

    Boston, MA, United States Tandym Group Full time

    A biotechnology company in Massachusetts is currently seeking an experienced IT professional to join their team in Boston as their new Director of IT, Clinical Development Systems. Partnering with the Clinical Development and Operations leaders, the Director of IT, Clinical Development Systems will be responsible for developing and executing against a...

  • Business Development Director

    1 week ago

    Boston, United States Prime Vigilance Ltd Full time

    We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality...

  • Business Development Director

    1 week ago

    Boston, United States PrimeVigilance Full time

    Job DescriptionJob DescriptionCompany DescriptionWe are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information,...