Associate Director/Director, Safety Scientist
$102K-$178K (Glassdoor est.)
Who are we?

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 and development efforts in hematologic and pulmonary diseases. In hematology, Acceleron and its global collaboration partner, Bristol Myers Squibb, are co-promoting newly approved REBLOZYL® (luspatercept-aamt), the first and only approved erythroid maturation agent, in the United States and are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes and myelofibrosis. Acceleron is also developing sotatercept for the treatment of pulmonary arterial hypertension, having recently reported positive topline results of the Phase 2 PULSAR trial and actively enrolling patients in the Phase 2 SPECTRA trial.

What’s in it for you?

The Safety Scientist is responsible for ensuring high quality safety surveillance activities including aggregate report production, safety management meeting coordination, signal detection and risk management activities for assigned products.

Reporting to the Medical Safety Director, she/he will 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 safety surveillance and individual case safety reporting are performed on-time for assigned products in compliance with global regulations.

What will you be doing?
Responsible for the technical and scientific support for safety surveillance and signal detection activities for assigned products via existing signal detection methodology and tools.
Responsible for the development of periodic (e.g. PBRER, DSUR, PADER) and ad-hoc safety reports for assigned products for submission to regulatory agencies around the world.
Collaborates with the Safety Medical Director to ensure that all information is available to allow for informed medical review and benefit-risk assessment.
Responsible for the quality of the final document using the procedures in place
Contribute in the evaluation of safety and supporting documents and responses to regulatory authorities.
Contribute in the development of risk management plans.
Review safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products.
Represent pharmacovigilance on cross-functional product/project teams as required.
Collaborate with PV team members to ensure appropriate and timely communication/dissemination of safety information.
Represent pharmacovigilance for regulatory inspections and audits and contribute in developing corrective action plans when needed.
In collaboration with Safety Medical Director, plan and conduct Safety Management Team (SMT) meetings and track follow-up actions.
What are we looking for?
Life Science Degree or Healthcare Professional (PharmD, PhD, MS, BS, RN, or RPh).
Post-graduate trainings in epidemiology (e.g. MPH) is an added benefit but not an absolute requirement.
Five years previous experience working in a (global) pharmaceutical Pharmacovigilance Department and among them atleast 3 years in safety surveillance or safety risk management.
Experience in clinical development and post marketing safety surveillance and reporting to Regulatory Authorities worldwide.
Competence in conducting safety data reviews, preparation of aggregate reports, signal detection and risk management plans for investigational and/or post marketed products.
Experience with MedDRA and drug coding reviews.
Knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance’s related to pharmacovigilance (e.g.E2B) and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety.
Ability to achieve compliant solutions to complex problems in which analysis of situations or data requires an in-depth, strategic evaluation of various factors
Must have excellent, concise writing skills, excellent communication and interpersonal skills, and experience in working in multidisciplinary teams
Demonstrated technical leadership and ability to influence across external functions and within internal team
How will you grow with us?

This opportunity will allow you to drive the Pharmacovigilance function at Acceleron 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.

FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO:

www.acceleronpharma.com
Acceleron Pharma
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Acceleron Pharma
