Our Global Quality Assurance group is looking for a Sr Manager Pharmacovigilance QA. The Sr. Manager QA PhV will play a lead role in the oversight and assessment of activities related to Safety Surveillance and Risk management to ensure robust systems and processes for global Pharmacovigilance (PhV) activities.
This position is responsible for providing PhV audit and assurance support for QA management and participate in QA oversight for global PhV activities of various teams within.
This job will include the execution of QA PhV audits and the provision of PhV guidance and advice across relevant Post-marketing and Clinical Development areas.
Essential Functions of the Job (Key responsibilities)
- Assist in the development of and the establishment and execution of the GVP audit program (Processes, affiliates, vendors, business partners and all others relevant structures/functions identified).
- Participate to the maintenance of the PhV Quality Management System including QA support for PhV supplier qualification, change control, deviations, review of SOPs with ensuring continuous process improvement.
- Establish robust collaboration with PhV Leaders, including Global Risk Management and Safety Surveillance team (Safety Medical and Scientists).
- Provide efficient QA support for the PhV teams in charge of Safety surveillance (signal detection and management, RSI determination, literature search, …) and the development of Aggregate reports (PSUR, PBER, DSUR).
- Review of key pharmacovigilance documents, e.g. PSMF, reports and regulatory submissions, as needed.
- Support the preparing, coordinating and hosting Inspections/Partner audits in collaboration with the PhV function.
- Coordinate responses and corrective/preventative actions from deviations, audits and regulatory inspection findings.
- Establish robust collaboration with other US Non-PhV functions (US Medical Affairs, US Medical Information) in order to ensure robust systems and processes in place for safety aspects.
QA PhV and Clinical global:
- Stay abreast of Pharmacovigilance and Safety regulations, US regulations, ICH GCP, and guidelines from other regulatory agencies for the management of safety post-marketing and safety clinical trials, as appropriate.
- Escalate to Global QA Clinical/PhV Management of internal and external serious non-compliance/deviations in a timely manner.
- Provide support for regulatory authority inspections including conducting pre-inspection audits and inspection readiness activities as assigned.
- Assist with the management of QA consultants performing audits on behalf of lncyte Corporation.
- Foster a relationship of trust and effective communication with functional stakeholder.
- Be knowledgeable with assigned lncyte compounds and protocols, and be able to understand advanced operational, scientific and/or medical problematic.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Minimum Bachelor's degree in a science or healthcare related discipline, or similarly conferred degree from a University.
- 3 - 10 years' experience in a pharmaceutical or bio-pharmaceutical company in a PV QA role with a minimum of 2 years' lead auditor experience performing GVP compliance audits of vendors and business partners.
- Ability to travel a minimum of 30%.
- Prior GVP I GCP inspection experience preferred.
- Thorough knowledge in GVP and in global regulatory requirements.
- Experience in managing Audit contractors.
- Strong Interpersonal skills, including organizational sense, rational and autonomy.
- Strong verbal and written communication skills with well-structured communication and presentation ability.
- Results focused which may require negotiating skills and diplomacy.
- English fluency written and spoken (the company language); Knowledge of other languages is an asset.