Abbott Pharmacovigilance Manager Opening - Pharma

Abbott Pharmacovigilance Manager Opening – Pharma

Abbott Pharma Job Opening. Pharma Job Opening. Abbott invites postgraduate and undergraduate Pharma candidates for the post of Manager. Executive job opening 2020. Interested and eligible candidates may apply for this job post. Check out all the details

EDUCATION:

  • Ideally licensed physician or graduate with a Medical, Pharmacy or Life Sciences degree.
    Computer literacy (Windows, MS Office).
  • Fluency in English language.

EXPERIENCE/QUALIFICATION:

  • At least three years of experience in the pharmaceutical industry in Pharmacovigilance,
  • Medical Affairs or Clinical development
  • Knowledge of Pharmaceutical Regulations in Asia, especially for pharmacovigilance
  • Attention to details, flexibility, commitment to quality
  • Availability for travel (30-50%)

POSITION ACCOUNTABILITY/SCOPE:

  • Application and maintenance of consistent standards for PV across all Affiliates
  • Adherence to global and local SOPs
  • Appropriate and adequate training for ASRs
  • Timely identification and appropriate response to areas of non-compliance
  • Audit and inspection readiness in Affiliates at all times
  • Real-time response to ASR questions
  • Administrative oversight of the GPV staff located in Mumbai, India.

PRIMARY JOB FUNCTION:

Oversight of the performance of Abbott Affiliate pharmacovigilance functions in the given region/territory to ensure they are in line with company standards and local legislative requirements.

  • Administrative supervisor of GPV Satellite organization based in India.
  • Liaising with other regional I&D functions.
  • Assume leadership for Medical Safety topics in the designated region/territory.

Compliance: Awareness of PV compliance and performance at the Affiliate level. Escalation of issues according to the applicable procedures.

Audits and Inspections: Appropriate support for CAPA activities and oversight of completion of activities

Training: Develop training matrix for Regional PV and local PV Staff (ASRs and back-ups). Organize Global PV Meetings to include technical PV training, GPV initiative updates, best practice sharing and to give ASRs opportunity to meet other ASRs and share experiences and issues.

PV Quality System: Support implementation of global SOPs at local level. Author global SOPs related to training (for local PV staff) and local PV system.

Advice and guidance: Provide ad hoc advice and support to ASRs on operational PV issues and liaise with GPV for resolution.

ASR Development: Provide feedback on potential ASR talent which may be redeployed in other regional/global PV roles

Local PVAs: Work with PV Contracts to maintain consistency in local SDEAs

Regulatory Intelligence: Understand local regulations and guidelines and assess potential impact on global process and procedures. Notify GPV and QPPV of potential impact and assist in determination of appropriate local or global strategy to accommodate requirements

Interfaces: Work in collaboration with the applicable stakeholders (e.g. Global Regulatory Affairs, Global Medical Affairs, Global Clinical Development, QA PV) in order to maintain a timely and complete exchange of information relevant to PV and optimize the support for the local PV staff.

Medical safety: support and guide ASRs regarding safety surveillance (incl. safety signaling, preparation of local annexes to globally prepared RMPs and local RMPs, PSUR planning and preparation, HHAs. Additionally, support and guidance for clinical studies and drug development, participation DRBs and in due diligence activities for regional L&A options.

Process improvement: Provide local area perspective on processes to GPV to enhance productivity and efficiency
Other: Sponsor/lead/contribute to certain local and global projects.

Apply Online

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