Senior Director, Pharmacovigilance Operations

Acceleron Pharma

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Operations
  • Post Date: 06/15/2021
  • Website: acceleronpharma.com
  • Company Address: 128 Sidney Street, Cambridge, MA, 02139

About Acceleron Pharma

Acceleron is a 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 superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

Job Description

The Sr. Director, Pharmacovigilance (PV) Operations will be responsible for creating, directing, and managing the company’s infrastructure and staff to support the operational aspects of the pharmacovigilance system, and adheres to all global regulatory requirements and internal processes and procedures. The qualified candidate will have experience in and perform multiple activities related to the overall global PV operations strategy across the portfolio including case management, database strategy, vendor oversight, compliance, inspection readiness, budget, contract management and trainings. The Sr. Director of PV Operations reports to the VP, Pharmacovigilance.

 

What will you be doing?

  • Provides strategic planning, implementation, and management of Acceleron Pharmacovigilance Operations activities.
  • Responsible for managing internal staff and external vendor allocated to PV operational activities, creating a highly efficient team across insourced and outsourced resources.
  • Provides expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and EU Good Pharmacovigilance Practice (GVP).
  • Builds and implements pharmacovigilance systems fully compliant with the applicable worldwide Health Authority PV regulations.
  • Ensures that the Safety Database supports the department needs, including specific workflows and reporting/querying functionalities.
  • Provides oversight of systems and MedDRA updates in collaboration with the relevant vendor(s).
  • Manages vendors and business partners. Provides vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics.
  • Develops and implements an inspection readiness program with the contribution of other PV and non-PV stakeholders.
  • Responsible for a compliant and quality execution of all operational activities related to case management and related activities.
  • Oversees timely submissions of expedited reports to the FDA & other health authorities.
  • Identifies deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level.
  • Establishes a system for prevention and correction of deviations to compliance with internal and external stakeholders, in collaboration with the Quality group.
  • Oversees the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate these trials and products.
  • Contributes to and implements department SOPs and work instructions related to the PV activities.
  • Effectively collaborates with key stakeholders at all levels in the organization.
  • Work closely with Manufacturing Quality to ensure the needed compliance with connecting and reporting between product quality complaints and adverse event and (in the future) with drug-device combination reporting obligations.
  • Represents PV as a leader on project teams, other departments, and committees.
  • Provide managerial support to direct reports with overall responsibility of leading, training, and mentoring for effective performance.
  • Other duties as assigned by the manager.

 

What are we looking for?

  • Life Science Degree or Healthcare Professional (PharmD, PhD, MS, BS, RN, or RPh).
  • Advanced degree in business and or project management (MBA, PMP) desired.
  • A minimum of 10 years of experience in Pharmacovigilance Operations in the biopharmaceutical industry, with at least 5 years of leadership and managerial experience in overseeing global/regional PV operations.
  • Prior experience in ICSR case processing, aggregate safety reporting, PV quality management systems, and PV compliance (including major PV inspections)
  • Solid knowledge of ICH guidelines relevant to PV and of PV regulation and legislation in the US and EMENA region.
  • Significant experience working with CROs, vendors, and relationship management.
  • Strong managerial skills across countries and ability to partner closely and effectively cross-functionally.
  • Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes.
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations.
  • Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks while working in a matrixed environment.
  • Ability to manage multiple projects in a fast-paced environment.
  • Ability to combine pharmacovigilance expertise with exceptional leadership (strategic thinking, people and resource management)

 

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 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.

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This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.