Senior Medical Director, Pharmacovigilance Jobs in Cambridge, MA at Acceleron Pharma
Title: Senior Medical Director, Pharmacovigilance
Company: Acceleron Pharma
Location: Cambridge, MA
Salary: $150K — $200K *
Category: Pharmaceuticals & Biotech
What’s in it for you?
The Senior Medical Director is a drug safety physician who monitors the safety profiles and provides periodic benefit-risk assessment for assigned products during the product lifecycle. He/she is responsible for safety surveillance, risk management, and risk communication for assigned products as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including labeling changes.
Reporting to the Head of Pharmacovigilance, the Senior Medical Director will lead cross-functional safety management team (SMT) and collaborate with other members of the pharmacovigilance team and cross-functionally including clinical, regulatory, contract research organizations (CROs), and drug development collaborators/partners to ensure that all clinical safety and benefit-risk assessment is performed adequately for assigned products.
What will you be doing?
Lead product safety surveillance and oversee evolving safety and benefit-risk profiles for assigned products
Lead cross-functional safety management team (SMT) for assigned products, and responsible for the on-going assessment of benefit-risk profiles and related actions during the product life cycle
Review safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the life cycle of assigned products
Responsible for the conducting signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
Represent pharmacovigilance on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, marketing documents, and other documents providing safety content
Responsible for strategy and key content of Risk Management documents (RMPs, REMS) and regulatory responses
Provide strategy and guidance to safety scientist in writing of periodic reports for assigned products; provide medical interpretation, review and approval
Responsible for up to date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents
Perform the medical review of all adverse event reports for seriousness, expectedness and causality
Collaborate with PV team members to ensure appropriate and timely communication/dissemination of safety information
Coach, mentor and manage safety scientist(s) supporting the surveillance activities for assigned products
Represent Pharmacovigilance function in leadership committees and activities both internally and externally when appropriate
Represent pharmacovigilance for regulatory inspections and audits and contribute in developing corrective action plans when needed
What are we looking for?
MD degree in a health science, with 3-5 years of relevant clinical experience
Post-graduate trainings in epidemiology (e.g. MPH) is an added benefit but not an absolute requirement
At least 5 years of experience in pharmaceutical industry within Drug safety/Pharmacovigilance with both investigational and marketed products
Experience with global BLA/NDA submissions and regulatory interactions a plus
Experience in therapeutic areas e.g. pulmonary arterial hypertension, hematology is preferred
Expert knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance’s related to pharmacovigilance and …
About Acceleron Pharma
Acceleron Pharma, Inc. is a public American "clinical stage biopharmaceutical company" based in Boston, Massachusetts with a broad focus on developing medicines that regulate the transforming growth factor beta (TGF-ß) superfamily of proteins, which play fundamental roles in the growth and repair of cells and tissues such as red blood cells, muscle, bone, and blood vessels. John Knopf, Jasbir Seehra, Tom Maniatis, Mark Ptashne and Wylie Vale formed the company in Cambridge, Massachusetts. The company began with a venture capital investment and opened its first laboratory in December 2003. The company tendered an initial public offering in September 2013.