Bachelor's degree in life science or healthcare; advanced degree preferred., Minimum 10 years of experience in a pharmaceutical/biopharmaceutical company., At least 7 years of Drug Safety experience with up-to-date knowledge of US and international PV regulations., Strong analytical skills, attention to detail, and problem-solving abilities..
Key responsabilities:
Establish and maintain departmental procedures and oversee training for continuous improvement.
Support pharmacovigilance activities including signal detection, literature surveillance, and medical review oversight.
Collaborate with various departments and provide expertise in PV activities for clinical project teams.
Participate in regulatory inspections, audits, and contribute to safety analysis reports and documentation.
Report This Job
Help us maintain the quality of our job listings. If you find any issues with this job post, please let us know.
Select the reason you're reporting this job:
Katalyst Healthcare's & Life Sciences (Katalyst HLS) is a Global Contract Research Organisation that provides End-to-End Clinical Research Services for Healthcare and Life Sciences companies globally. At Katalyst HLS offers ICH-GCP compliant clinical trial services from Phase I–IV in all key therapeutic areas to support clinical development and research requirements and also provides validation, quality and regulatory services for Pharma/Bio-Pharma/Medical Device industries. Services:- Clinical Trial Management- Clinical Data Management- Biostatistics & Statistical Programming- Medical Writing- Pharmacovigilance- Quality and Regulatory Affairs- GMP, GLP and GCP Validations- Manufacturing Process Validations- Equipments & Instruments Validations- Computer Systems Validations- Human Resourcing
Establishes and maintains departmental procedures; oversees training and continuous improvement.
Support DSP in pharmacovigilance activities including: signal detection and tracking activities, literature surveillance, oversight of medical review performed by outsourced vendor
Collaborate with DSP safety physicians with PV activities as assigned
Writing safety analysis reports
Oversight of medical review and aggregate report activities performed by outsourced vendors
Support clinical project teams for investigational products; provide project teams providing expertise in PV activities
Collaborate with Clinical Research and Development, medical Affairs, Regulatory Affairs
Provide Leadership in the development, implementation, and maintenance of robust procedures for PV activities within the DSP department
Participate on the Safety Evaluation Group with local and global drug safety colleagues to monitor and discuss safety signal evaluation topics
Contribute to the writing and compilation of PADERs, Annual reports and PSURs/PBRER.
Author and review department SOPs as needed.
Participate in Regulatory Inspections, external audits and investigator meetings
Drug safety representative on Purdue intradepartmental committee for review and approval of clinical trial protocol language and clinical study processes
Acts as a Subject Matter Expert in PV regulatory inspections and internal/external audits.
Collaborates with internal stakeholders and Purdue subsidiaries to establish and maintain the Corporate AE Policy.
Collaborate with Drug Safety Operations and Drug Safety Systems as needed, to ensure appropriate metrics per SOP.
Requirements:
Bachelor's degree (advanced degree preferred) in life science or healthcare (e.g. nursing, pharmacy)
Minimum 10 years of experience in a pharmaceutical/biopharmaceutical company
Minimum 7 years of Drug Safety experience
Up-to-date knowledge of US and international PV regulations and best practices
Thinks globally and considers present and future impacts when making recommendations
Experience with PV vendor and business partner oversight and contract/agreement management
Strong negotiation and problem-solving skills
Analytical skills and attention to detail
Accountability – takes ownership of deliverables
Required profile
Experience
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.