ACCELERON PHARMA INC Associate Director, Pharmacovigilance Operation and Alliance Management Salary in the United States

Who are we?

Acceleron is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta 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, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular program with ACE-083, a locally-acting Myostatin+ agent in Phase 2 development in Charcot-Marie-Tooth disease, and is conducting a Phase 2 pulmonary program with sotatercept in pulmonary arterial hypertension.

What’s in it for you?

The Associate Director of Pharmacovigilance Operation and Alliance Management will contribute in the strategy, planning, execution, and maintenance of safety database and outsourced PV activities through partners and contract research organizations. Reporting to the Director of PV this hire will provide support in contract management, vendor oversight, safety data exchange with partners in compliance with the appropriate regulatory guidelines. He/ She will interface with various functional areas and external resources, collaborating with other members of pharmacovigilance team, clinical, regulatory, contract research organizations (CROs), and drug development collaborators/partners to ensure optimal safety reporting of on-going clinical trials and post-marketing for Acceleron products.

What will you be doing?

• Contribute in and provide oversight on the maintenance of safety database and safety related systems through contract research organization.
•  Oversee the process flow and timely reporting of individual case safety reports (ICSRs) originating from clinical studies and post-marketing in collaboration with the CROs.
• Support PV Director in developing contracts and the day to day activities with partners /CROs related to the pharmacovigilance operations, budget, database and systems.
• Monitor CRO performance (compliance/ quality) to ensure optimal safety assessment and reporting of ongoing clinical trials and post-marketing
• Prepare for regulatory inspections and audits and contribute in developing corrective action plans when needed
• Participate on cross-functional product/project teams, partner organizations and CROs in order to ensure timely processing of adverse events and ensure high compliance in regulatory reporting.
• Collaborate with PV team members to ensure appropriate and timely communication/dissemination of safety information from the database to internal members and external stakeholders for signal detection, aggregate reports and regulatory responses.
• Monitor industry best practices and global safety regulations to ensure continuous compliance
• Contribute to quality, compliance metrics and corrective actions as required.
• Provide project management support for departmental projects and initiatives as required

What are we looking for?

• Life sciences degree with previous experience in vendor and project management
• Advanced degree in management (e.g. MBA, PMP) preferred
• Experience and familiarity with safety databases such as Oracle Argus and/or ARISg is must
• Preferred minimum 5 years of experience in US and/or international pharmacovigilance/drug safety and at least 3 years of experience in pharmacovigilance operations in Pharmaceutical and/or Biotechnology industry
• Experience with vendor, project and alliance management
• Must have demonstrated working knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance’s related to pharmacovigilance and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety
• Has the capacity to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
• Must have excellent, concise writing skills, excellent communication and interpersonal skills, and experience in working in multidisciplinary teams
• Has the ability to work independently with minimal supervision, multi-task with attention to detail, manage multiple projects under tight deadlines, and independently identify problems and effectively offer solutions

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