-
Nuvalent, Inc. Cambridge, United States**The Company**: · With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans ...
-
Medical Director, Pharmacovigilance
1 week ago
Deciphera Waltham, United StatesCompany 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 ...
-
Medical Director, Pharmacovigilance
2 weeks ago
Deciphera Pharmaceuticals Waltham, MA, United StatesCompany 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 ...
-
Medical Director, Pharmacovigilance
2 weeks ago
Deciphera Pharmaceuticals Waltham, United StatesJob Description · Job DescriptionCompany 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 inhib ...
-
Medical Director, Pharmacovigilance
2 weeks ago
Deciphera Pharmaceuticals Watertown, United StatesCompany 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 ...
-
Director, Pharmacovigilance
1 week ago
Ironwood Pharmaceuticals Boston, United States Full timeIronwood 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 ...
-
Director, Pharmacovigilance
1 week ago
Ironwood Pharmaceuticals Boston, United States Full timeIronwood 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 ...
-
Director, Pharmacovigilance
3 weeks ago
Ironwood Pharmaceuticals Boston, MA, United StatesIronwood 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 ...
-
director, pharmacovigilance operations
3 weeks ago
BioSpace Cambridge, MA, United StatesJob Details · About the role · Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As the Director, Pharmacovigila ...
-
Morphic Holding, Inc. Waltham, United States· 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 collaborati ...
-
BioSpace Waltham, United StatesJob 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 FORCETM platform, Dyne is developing modern olig ...
-
Dyne Therapeutics, Inc. Waltham, United StatesCompany 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 thera ...
-
Director, Pharmacovigilance Operations
3 weeks ago
Sana Biotechnology Cambridge, United States Full timeAbout the role · Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As the Director, Pharmacovigilance Operations ...
-
Senior Director, Pharmacovigilance
1 week ago
Beam Therapeutics Inc. Cambridge, United StatesPosition Overview: · Unique opportunity to join a growing Pharmacovigilance (PV) team working on cutting edge therapies in the gene editing space. This senior PV role will be responsible for oversight and management of activities pertaining to Beam's drug safety and pharmacovigi ...
-
Sr. Director, Pharmacovigilance
3 weeks ago
The Steely Group Cambridge, United StatesTo promote proper use by conducting necessary internal and external communication such as consultation with the domestic regulatory authority so that safety measures planned based on the risk/benefit evaluation of each product can be appropriately im Regulatory, Director, Busines ...
-
Apex Systems Waltham, MA, United StatesDirector/ Senior Director/ Executive Director of Pharmacovigilance and Drug Safety · Sr. Director/Executive Director PV and Drug Safety · Location: Waltham, MA (Onsite) · Therapeutic Area: Immuno-Oncology · Job Overview: This role will be responsible for managing drug safet ...
-
Dragonfly Therapeutics Waltham, MA, United StatesDragonfly Therapeutics seeks a Director/Sr. Director/Executive Director of Pharmacovigilence & Drug Safety to support product safety and compliance. The successful candidate will report to the VP of Pharmacoviglence and be responsible for managing drug safety data to support sign ...
-
Dyne Therapeutics Waltham, United States Full timeCompany 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 the ...
-
Senior Director, Pharmacovigilance
4 days ago
Beam Therapeutics Inc. Cambridge, United StatesPosition Overview: · Unique opportunity to join a growing Pharmacovigilance (PV) team working on cutting edge therapies in the gene editing space. This senior PV role will be responsible for oversight and management of activities pertaining to Beam's drug safety and pharmacovigi ...
-
Senior Director, Pharmacovigilance
3 days ago
Beam Therapeutics Inc. Cambridge, United StatesPosition Overview: · Unique opportunity to join a growing Pharmacovigilance (PV) team working on cutting edge therapies in the gene editing space. This senior PV role will be responsible for oversight and management of activities pertaining to Beams drug safety and pharmacovigil ...
Medical Director, Pharmacovigilance - Waltham, United States - Deciphera Pharmaceuticals
Description
Job DescriptionIncrease 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.
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.
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.
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
