Medical Director, Pharmacovigilance

2 weeks ago

Waltham, United States Deciphera Pharmaceuticals Full time

Job Description

Increase your chances of an interview by reading the following overview of this role before making an application.

We are seeking a Medical Director.  This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office.

The Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. Responsible for keeping upper management informed of safety issues. May represent Deciphera, Drug Safety and Risk Management at internal and external meetings. May be appointed as the Safety lead for a specific compound / product.

The successful candidate will demonstrate the flexibility and capability to function at a high level and will be comfortable working in an entrepreneurial environment to advance the safety understanding of compounds through life cycle. The individual who assumes this position will interact with multiple levels of management.

What You’ll Do:

Leads and provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned product.

Provides pharmacovigilance expertise to oversee and lead decision making based on  risk/benefit evaluation, data analysis, interpretation, risk assessment and mitigation

Perform medical review and assessment of adverse event reports for marketed and investigational products, adhering to documented procedures and company/vendor timelines

Ensure that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment

Provide medical support to cross functional team for protocol-related issues including protocol clarifications for safety topics, inclusion/exclusion determinations from safety perspective, and issues of patient safety and/or eligibility

Assist with development of the protocol, Investigative Drug Brochure (IDB), Informed Consent Forms and/or Case Report Forms (CRFs)

Perform review and clarification of trial-related Adverse Events (AEs), coding and consistency in assessment

Perform medical case review of Serious Adverse Events (SAEs), including review of coding, consistency in assessment, case documentation and patient narrative

Attend Kick-Off meetings, weekly team meetings, and vendor meetings, and other meetings as needed or requested

Support inspections and audits, act as a subject matter expert for the assigned program (s)

Provide training on product and medical review to vendor/ team members as needed

Completes tasks on time or notifies appropriate person with an alternate plan.

Participate in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed

Attend/lead Safety committee meeting to support key decision-making, drive conclusions and develop next steps

Work closely with Regulatory Affairs, and other cross functional team members to ensure oversight of critical safety issues and benefit-risk assessments

Participate in development and maintenance of risk management plans and REMS as applicable.

Key member on the Product Safety Committee; presentation of safety issues, signal evaluations, and proposed risk mitigation strategies

Provide medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports

Contribute to preparation of relevant regulatory documents and responses to regulatory agency, IRB, Site and Medical information queries

Provide consultation for medically related questions from participating vendors, affiliates, etc.

Use in-depth knowledge of Pharmacovigilance science and Regulatory Guidance  to provide expertise and insight to cross-functional colleagues as appropriate

Develop/assist in creation of internal SOP and review vendor SOPs as needed.

Support in Inspections and Audits as needed

Other relevant duties as assigned

  • Medical Director, Pharmacovigilance

    1 day ago

    Waltham, United States Deciphera Full time

    Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled...

  • Executive Director, Drug Safety and Pharmacovigilance

    4 weeks ago

    Waltham, United States Morphic Holding, Inc. Full time

    Description About Morphic Therapeutic Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrödinger, Morphic is advancing its pipeline and discovery...

  • Executive Medical Director, Drug Safety and Pharmacovigilance

    4 weeks ago

    Waltham, United States MURAL ONCOLOGY PLC Full time

    The Mural team brings together oncology expertise and passion to make an impact on patients' lives. We are seeking a highly motivated individual to join our team. Overview The Executive Medical Director serves as the functional head of DSPV, and is accountable for the management, mentoring and development of assigned benefit-risk management staff as well...

  • Vice President, Pharmacovigilance

    1 day ago

    Waltham, United States Viridian Therapeutics Inc. Full time

    Description At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Reporting to the Chief...

  • Senior Director, Drug Safety and Pharmacovigilance

    4 weeks ago

    Waltham, United States BioSpace Full time

    Job DetailsCompany Overview: 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 modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to...

  • Senior Director, Drug Safety and Pharmacovigilance

    1 month ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: 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 modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Senior Director, Drug Safety and Pharmacovigilance

    5 hours ago

    Waltham, United States BioSpace, Inc. Full time

    Job Details Company Overview: 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 modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to...

  • Senior Director, Drug Safety and Pharmacovigilance

    1 month ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview: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 FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Senior Manager, Pharmacovigilance and Risk Management

    4 weeks ago

    Waltham, United States Deciphera Full time

    Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled...

  • Senior Manager, Pharmacovigilance Quality

    9 hours ago

    Waltham, United States Deciphera Pharmaceuticals Full time

    Job DescriptionJob DescriptionCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of...

  • Senior Manager, Pharmacovigilance and Risk Management

    4 weeks ago

    Waltham, United States Deciphera Pharmaceuticals Full time

    Job DescriptionJob DescriptionCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of...

  • Executive Director, Medical Director

    7 days ago

    Waltham, United States BioSpace, Inc. Full time

    Job Details Company Overview: 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 modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to...

  • Executive Director, Medical Director

    1 month ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: 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 modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Executive Director, Medical Director

    4 weeks ago

    Waltham, United States BioSpace Full time

    Job DetailsCompany Overview: 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 modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to...

  • Executive Director, Medical Director

    1 month ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview: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 FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Executive Medical Director, Drug Safety and Pharmacovigilance

    4 weeks ago

    Waltham, United States Alkermes Full time

    Overview: The Executive Medical Director serves as a senior member of the DSPV leadership team, accountable for the management, mentoring and development of assigned benefit-risk management staff as well as serving as a global safety officer for assigned investigational and/or marketed products. Reporting to the Head of DSPV, the Executive Medical Director...

  • SVP, Head of Clinical Development

    1 month ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: 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 modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • SVP, Head of Clinical Development

    4 weeks ago

    Waltham, United States BioSpace Full time

    Job DetailsCompany Overview: 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 modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to...

  • SVP, Head of Clinical Development

    1 month ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview: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 FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Director, Clinical Research and Early Programmes Immunology

    3 weeks ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    Site Name: UK - Hertfordshire - Stevenage, Belgium-Wavre, UK - London - Brentford, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence Posted Date: May 3 2024 A Director, Clinical Research and Early Programmes Immunology is sought to provide clinical and scientific insights to the immunology franchise including...