What’s in it for you?
The Associate Director, Pharmacovigilance (PV) Quality will be responsible for providing PV Quality support of clinical programs at Acceleron. This individual will be the subject matter expert in Good Pharmacovigilance Practice (GVP), develop standards and partner with Clinical Operations, Regulatory, Biostatistics, Pharmacovigilance, Medical Research, PV Vendor(s) or Contract Research Organization(s), and other functions to establish and document PV processes and procedures. The AD of PV Quality will ensure compliance with applicable global regulations with regards to sponsor oversight of Acceleron’s clinical programs.
What will you be doing?
- Oversee pharmacovigilance (PV) quality and compliance systems including establishing standards, department training requirements, monitoring department compliance performance, implementing continuous improvement actions and good documentation practice for PV.
- Support the growth of the PV QMS, including continuous improvement of systems, processes and procedures.
- Work closely with the PV leadership team and PV vendors on the development and maintenance of quality and compliance
- Provide input on Drug Safety/PV Vendor oversight, including key performance indicator (KPI) metrics generation and review, develop and track vendor compliance metrics, quality and timeliness of deliverables and continuous improvement in collaboration with PV operations.
- Provide data verification review and support for pharmacovigilance right to operate (RTO) documents for regulatory submissions (e.g. Development Safety Update Reports (DSUR).
- Provide oversight of QA consultants performing PV audits of vendors, processes and systems. Review and provide feedback on audit reports. Manage corrective and preventative actions (CAPA) in collaboration with PV Group. Maintain and file related documentation as required.
- Ensure that PV audit results are formally and consistently tracked, recorded, reported, trended. Ensure that corrective/preventive actions have been identified, documented and are effective.
- Support Quality management initiatives and Quality improvement plans for QA and defined business.
- Support PV Group in developing and conducting training
- Together with PV Group, ensure PV activities are conducted in compliance with applicable global regulations and legislation, by-laws, regional and local guidelines and standards including EU, EU-GVP, ICH, and FDA standards.
- Maintain high level of knowledge of current global pharmacovigilance regulations, updates to regulations and good pharmacovigilance practices.
- Responsible for PV inspection readiness and tracking of documentation
What are we looking for?
Acceleron is seeking candidates who are self-motivated and directed; who operate with the highest integrity, embrace an atmosphere of continuous improvement, and share our commitment to data-driven decision making.
- Bachelor’s Degree in a scientific discipline
- 8-10 years of experience working in the pharmaceutical/biotech industry in the fields of quality, compliance, operations or medical safety, including at least 3 years of experience in a Quality function
- Excellent knowledge of EU and FDA legislation and ICH PV guidelines with the ability to proactively communicate this knowledge to internal/external stakeholders. Knowledge of Japan/Asia regulations highly desirable
- Exhibits leadership skills that promote team collaboration, foster open dialog, and maintain an inclusive collaborative environment
- Experience authoring and implementing global PV procedures and training
- Proactive in identifying opportunities for improvement along with strong problem solving and negotiation skills.
- Ability to remain objective/autonomous in implementing the Quality Program, while at the same time taking ownership and proactively working with the rest of the team to achieve the desired quality objectives
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization
- Strong verbal and written communication skills
How will you grow with us?
This candidate will advance Acceleron’s innovative pipeline through proactively developing and influencing quality specific standards. As the pipeline progresses, this candidate will increase their strategic planning skills to align pipeline progression to the regulatory climate and global footprint.
*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