Remote Drug Safety Associate III Apply
Overview
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client manufactures pain medicines such as hydromorphone, oxycodone, fentanyl, codeine, and hydrocodone. It makes drugs such as MS Contin, OxyContin, and Ryzolt. In 1972, Contin (a controlled drug-release system) was developed.
Job Title: Drug Safety Associate III
Location: Stamford CT 06901
Duration: 12 Months
Job Type: Contract
Work Type: Remote
Job Summary:
- The incumbent must have good knowledge of the PV end-to end process and will leverage this knowledge to implement efficiencies/cost savings.
- The incumbent will be responsible for the implementation, execution, training, continuous improvement, and oversight of matters pertaining to PV alliances and policies.
- The incumbent will liaise with internal and external stakeholders, subsidiaries, Independent Associated Companies (IACs), business partners, and vendors as needed to establish and maintain policies as well as implement any corrective/preventive actions needed to ensure compliance.
Primary Responsibilities
- 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 client 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 client 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.
Education and Experience 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
Necessary Knowledge, Skills, and Abilities
- 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
TekWissen Group is an equal opportunity employer supporting workforce diversity.
