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JOBTITLE 职位 : PV Specialist/药物警戒专员 DEPARTMENT 部门 : - LOCATION 地点 : 上海

RESPONSIBILITIES: Major PV Responsibilities/Activities:
  • Qualified PV coverage and processes for back-up coverage (including coverage outside of business hours)

  • PV training of the Affiliate staff

  • PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance

  • Prompt and direct notification of Global Pharmacovigilance (GPV) / Qualified Person of Pharmacovigilance (QPPV) of defined items at relevant SOPs

  • Monitoring of Affiliate PV system performance and compliance, and resolving of nonconformities

  • Handling of internal PV audits and inspections from regulatory authorities

  • Affiliate Individual Case Safety Report (ICSR) management (that is, receipt, documentation, forwarding to GPV, tracking, expedited reporting, etc.)

  • Collection of safety data and other PV-related responsibilities in relation to interventional studies (clinical trials)

  • Collection of safety data and other PV-related responsibilities in relation to organized data collection schemes (that is, non-interventional studies, registries, patient support programs, market research programs, etc.)

  • Local screening of scientific literature and social media for safety information

  • Periodic safety reporting (that is, in collaboration with EPD GPV regarding scheduling, local submissions, etc.)

  • Handling of inquiries relating to product safety including regulatory authority inquiries

  • Handling of safety information arising from product complaints

  • If applicable, local implementation and tracking of RMP activities resulting from global RMPs (Risk Management Plan)

  • Contribution to product labelling changes

  • Consideration of PV matters during locally performed due diligence activities and locally negotiated contractual agreements, and exchange of safety information as defined in safety data exchange agreements

  • Record retention (archiving)

  • All ICSR information received originally at the affiliate should be archived locally.

  • For products registered only in one country outside the EU/EEA (ex-EU/EEA), additionally the following PV-related activities need to be performed at the Affiliate level, if/as required according to local regulations

Play the role of ASR backup for China Affiliate if applicable
  • the ASR backup covers for the absence of the ASR whenever needed, including all applicable PV activities

Backup Responsibilities/Activities upon necessity:
  • Handle medical inquiries from both internal and external customers on relative therapeutic area

  • Maintain and improve affiliate medical information database and system

  • Coordinate medical projects, medical Magzines and other medical team initiated programs..

  • Ensure all the activities compliant to related SOPs and working instruction. Prepare for internal & external audit or inspection

REQUIREMENTS:
  • Industry experiences: Bachelor degree or above in clinical medicine or pharmacology; Minimum 1 year experience in pharmaceutical industry

  • Position experiences:

  • Experiences in medical department of multinational pharmaceutical company is preferred

  • With work experience of pharmacovigilance and/or medical information

  • Language Skills: Fluent English in reading, writing and oral communication

  • Computer Skills: Microsoft Office software, literature retrieval skills

  • Mobility: Less than 15%

  • Certificate Required: NA

  • Other Special requirement:

  • Strong communication and presentation skill

  • Familiar with the local authoritative PV regulation