Senior Medical Director, Pharmacovigilance
What’s in it for you?
The 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 Medical Director will lead cross-functional safety management team (SMT) and collaborate with other members of 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
- Perform the medical review of all adverse event reports for seriousness, expectedness and causality.
- 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 safety signal detection activities, including monitoring, evaluation, interpretation 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
- Collaborate with Safety surveillance and PV operation team members to ensure appropriate and timely assessment and communication/dissemination of safety information
- Represent Pharmacovigilance function in 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 with 3-5 years of relevant clinical practice experience
- At least 5 years of experience in pharmaceutical industry with at least 3 years in Drug safety/Pharmacovigilance with both investigational and marketed products
- Experience with routine PV activities such as signal detection, literature monitoring, ICSR medical review and aggregate safety reports writing required.
- Experience with global BLA/IND submissions and regulatory interactions.
- Post-graduate trainings in epidemiology (e.g. MPH) is an added benefit but not an absolute requirement
- Experience in therapeutic areas e.g. pulmonary/nephrology preferred
- Expert knowledge on ICH, US & EU regulations and requirements for Pharmacovigilance
- Ability to understand scientific/clinical information and apply communication, negotiation and organizational skills to interact seamlessly both internally and externally on drug safety/pharmacovigilance.
- Must have excellent, concise writing skills, excellent communication and interpersonal skills, and experience in leading and/or working in multidisciplinary teams
How will you grow with us?
This opportunity will allow you to provide strategic direction using your clinical/ Pharmacovigilance expertise to ensure successful product development and approval in alignment with company objectives while working with a growing team and collaborating with knowledgeable and passionate cross-functional team members. It is an exciting time to work at Acceleron, with our company growth and advancing drug pipeline. You will tackle exciting challenges in a fast-paced environment and play an important role to further develop our drug safety function. Grow in your career and join our team!
*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.
*Recruiters - please do not send unsolicited resumes to this posting.
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Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron’s leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its research, development, and commercialization efforts in pulmonary and hematologic diseases. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension (PAH), having reported positive topline results of the PULSAR Phase 2 trial. The Company is currently planning multiple Phase 3 trials with the potential to support its long-term vision of establishing sotatercept as a backbone therapy for patients with PAH at all stages of the disease. Acceleron is also investigating the potential of its early-stage pulmonary candidate, ACE-1334, which it plans to advance into a Phase 1b/2 trial in systemic sclerosis-associated interstitial lung disease (SSc-ILD) next year. In hematology, REBLOZYL® (luspatercept-aamt) is the first and only erythroid maturation agent approved in the United States, Europe, and Canada for the treatment of anemia in certain blood disorders. REBLOZYL is part of a global collaboration partnership with Bristol Myers Squibb. The Companies co-promote REBLOZYL in the United States and are also developing luspatercept for the treatment of anemia in patient populations of myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.