PV Specialist

     

JOB DESCRIPTION:

Primary Job Function:

The Affiliate Safety Representative ASR back up in India is supporting the ASR in all activities related to pharmacovigilance (PV) for both Abbott EPD investigational and registered medicinal products under Abbott Healthcare Private Limited (AHPL) and Abbott India Limited (AIL), are performed at Affiliate level in accordance with internal Abbott policies and procedures as well as with local regulatory requirements. The ASR Back up also ensures the same for neighboring countries of Nepal, Bhutan, Maldives and Srilanka. This includes interface of Abbott EPD with local health authorities and represents pharmacovigilance internally within the Affiliate organization. Serves as back-up for ASR for all applicable PV activities.

Core Job Responsibilities:

• Quality management system: Maintenance of the Affiliate PV System Country Chapter and additional local PV procedures, forms, training matrix and templates
• PV business continuity planning and notification of any business interruptions that pose a th reat locally or globally to pharmacovigilance processes or endanger regulatory compliance
• Receipt, recording, and reconciliation of safety information
• Safety surveillance including literature and health authority website screening and preparation of local periodic safety reports and Risk Management Plans
• Regulatory submission of safety information
• Basic PV training of local EPD staff
• PV record retention and archiving
• Implementation of out-of-office coverage for receiving and recording safety-relevant information
• Maintenance of local PV product list
• Ensure PV matters in local interventional studies and local non-interventional organized data collection schemes
• Negotiation and implementation of local commercial pharmacovigilance agreements and local pharmacovigilance service agreements
• Due Diligence for product acquisition or in-licensing negotiated by an Affiliate organization
• Provision of local PV Compliance metrics and management of non-compliances
• Coordination/management of PV audits and inspections at the Affiliate level
• Ensure vigilance compliant to local legislation for Abbott EPD products beyond medicinal products such as medical devices and food supplements
• Review of local Prescribing Information (PI)
• Ensure compliance to the regulatory requirement for all EPD product with India, Nepal, Bhutan, Sri Lanka and Maldives region.
• Review and action Market research studies (MRS)/ Patient Support Program (PSP)/ digital product/ website etc. from PV aspects
• Prepare and maintain of Pharmacovigilance System Sub File (PSSF)

Supervisory/Management Responsibilities:

Direct Reports: None

Indirect Reports: None

Position Accountability/Scope:

The role takes responsibility for implementation and maintenance of a functional and compliant local PV system: 

• Implementation of local legislative and Abbott internal requirements in India, Nepal, Bhutan, Maldives & Srilanka, Local PV interface to Health Authorities
• PV point of contact for Affiliate non-PV functions and GPV headquarter
• Works in collaboration with local non-PV stakeholders to maintain a timely and complete exchange of PV-relevant information Supports the Manager PV Regional or GPV headquarter for specific global projects, as assigned

Minimum Education:

Ideally graduate with a Life Sciences or Pharmacy degree or equivalent qualification

Minimum Experience/Training Required:

• PV experience in pharmaceutical company is preferred
• Understanding of local PV regulation
• Ability to give attention to the detail
• Computer literacy (Windows, MS Office)
• Good English language skills

Good communication skills with internal and external stakeholders

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Medical & Scientific Affairs

     

DIVISION:

EPD Established Pharma

        

LOCATION:

India > Mumbai : BKC Building

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)