Overview

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

Job Description

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.