Associate Director, Pharmacovigilance Operations

Location
Brisbane, California, United States
Posted
Oct 11, 2020
Ref
1393585490
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Being a part of MyoKardia means you are a pioneer at heart, a go getter, a part of something meaningful . We push the boundaries, embrace uncertainty and challenge conventional thinking to make the biggest impact on people's lives - because we believe that a better solution is out there. We roll up our sleeves and get to work on making things happen - when the outcome of our work changes lives, action is a moral must. Each of us has a hand in shaping the future of our company, our industry and people's lives because the passion in each and every one of us is what makes the difference. If you are someone who dares to explore the unknown; who takes action in the face of uncertainty; who is passionate and driven about making a real difference in people's lives... then you belong at MyoKardia.

MyoKardia is passionate about breakthrough science and transforming the treatment of genetic heart disease through a targeted medicine approach. Our clinical program in hypertrophic cardiomyopathy (HCM) has advanced beyond Phase 3 and progressed to the regulatory filing stage. In addition, programs for treatment of HFrEF, atrial fibrillation and secondary programs for HCM are progressing leading to growth in our Research and Development organization. As a patient-focused company, the Pharmacovigilance function led by a VP of Pharmacovigilance is growing to ensure the highest level of quality and full preparedness for later stages of development, potential approval and post-approval activities. This role of Associate Director, PV Operations will report directly to the Head of PV Operations and will be integral to building the functional PV organization to support clinical development, submission and post-approval activities.

The Position

The Associate Director, PV Operations will be responsible for the core PV operational functions including Case Management, Drug Safety Systems, Alliance and Vendor Management, and Quality Management. This individual will overseeall aspects of adverse event collection, processing and reporting from clinical trials, post marketing and other sources, as applicable.

The Associate Director will work closely with Head, PV Operations andwill provide strategic guidance involved in adverse event collection and safety management throughout the lifecycle of MyoKardia's novel compounds.

Primary Responsibilities
  • Support the oversight of the global Pharmacovigilance (PV) system to enable compliance with applicable regulatory PV requirements and guidance.
  • Manage ICSR collection, processing and reporting activities, including associated quality and training activities to ensure regulatory timelines and global standards are met.
  • Work effectively with MyoKardia Quality organization to ensure up-to-date processes and procedures for operational activities in the end-to-end ICSR process.
  • Provide appropriate oversight of the PV vendor performing case management and study support activities.
  • Support quality management function within PV to ensure compliance with local and international safety requirements and regulatory inspection readiness in collaboration with QA.
  • Support development of departmental procedural documents in support of QMS infrastructure.
  • Provide appropriate oversight of the Argus hosting vendor and collaborate with IT and QA on safety database related activities.
  • Manage development of Pharmacovigilance agreements (PVAs) and safety exchange agreements (SDEAs) with license partners and distributors in support of PV collaborations.
  • Provide expertise on PV operational processes to clinical, developmental and marketing teams, plus other stakeholders, as required.

Education/Experience
  • Bachelor's/Master's in a field within Biomedical Sciences or Pharmaceutical Sciences or related Healthcare profession.
  • Minimum 8-10 years for experience in pharmaceutical safety including a thorough understanding of safety operations and global regulatory requirements, and a broad understanding and/or experience in downstream activities such as signal detection and evaluation as well as risk management activities.
  • Demonstrated competence in obtaining, analyzing, disseminating and reporting safety information in compliance with global regulations.
  • Proven track record in managing complex, cross-functional projects including those with a global scope.
  • Demonstrated experience in managing business process outsourcing vendors and relationships
  • Strong relationship building skills, with ability to interact effectively in a multifunctional, multicultural, growing organization.
  • Ability to operate objectively and independently as a leader and as a member of a team, as required.
  • Ability to interpret and apply applicable regulations to resolve issues and ability to develop business solutions to complex problems.
  • Ability to operate and thrive in a fast-paced environment; demonstrated flexibility, attention to detail and quality focused.
  • Strong organizational, project management, technical and problem-solving skills.
  • Ability to mentor, and coach within PV and cross functionally.
  • A team collaborator who can produce positive results in both hierarchical and cross-functional matrixes through building trust and being culturally aware.
  • Well-developed presentation, communication and interpersonal skills, including strong oral and written communication skills.
  • Experience and extensive working knowledge of MedDRA, Proprietary safety databases (i.e.: ARISg, ARGUS), Microsoft Office suite (Word, Excel, PowerPoint)
  • Travel: up to 15%