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PV Country Head IN 

POSITION PURPOSE:

The Pharmacovigilance Country Head (PVCH) is responsible for Pharmacovigilance (PV) in India, Nepal, Bangladesh, Bhutan and SriLanka working towards excellence to ensure the safe and appropriate use and the long- term medical potential of company’s products. The PVCH is responsible and accountable for directing, managing and improving all.

Pharmacovigilance activities for all Pharma and Consumer Health products, including contrast media products from Radiology according to India, Nepal, Bangladesh, Bhutan and Sri Lanka legislation and as devolved from Pharmacovigilance (PV). The PVCH provides medical safety governance to protect the patients, the products and the Bayer group with special focus on the India, Nepal, Bangladesh, Bhutan and SriLanka public health needs. The PVCH assures constant monitoring of national PV regulatory requirements and compliance with national and relevant international safety regulations.

YOUR TASKS AND RESPONSIBILITIES:

• Leads and manages India, Nepal, Bangladesh, Bhutan and Sri Lanka PV team.
• Leads the local Safety Management Team and liaise with the relevant expert functions in the local Safety Risk Management Plan development and intervention implementation activities.
• Works with the PV Regional Centre (PVRC) and maintains oversight on appropriate execution of delegated tasks
• Provides guidance in all PV and safety matters: Is therefore actively participating in local safety issue and crisis management in collaboration with the Headquarter.
• Reviews the PV components of all domestic study protocols and informed consents and ensures that these parts are compliant with the
• PV standards and the protocol template.
• Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations(e.g. Digital Activities, Active-Online-Listening programs) to ensure Pharmacovigilance principles are applied in all interactions with patients
• Represents Bayer’s PV system on a local level and for the countries in his/her jurisdiction and keeps the PVRC and global PV organization aware of relevant changes in the local context. 
• Being accountable for all PV matter toward the local HA and the local organization.
• Being responsible to escalate any safety relevant matters and take respective actions to safeguards appropriately use and the benefit risk balance of Bayer’s products on a local level.
• Review of local relevant medical literature according with the PV standard operations and procedures.
• Regular review and analysis of local regulatory context.
• Assists in the maintenance of company’s compliance with respect to laws, regulations and guidance associated with the licensure of Bayer medicinal products with respect to patient safety and assures the correct implementation and observation of all safety related Quality System Documents (QSD).
• Education and training within the local organization;documentation of topics addressed during the training and of participants in the training.
• Assures the collection, review, processing and distribution of adverse event information on a country level regarding the Bayer products in all therapeutic areas; guides submission of Individual Case
• Safety Reports to the local Health Authorities of the India, Nepal, Bangladesh, Bhutan and Sri Lanka according to the local regulations.

 WHO YOU ARE:

• Advanced life sciences degree, preferably medical doctor, or equal through experience
• A minimum of 3-5 years of experience in a (global) healthcare organization, esp. Clinical Development and/or Medical Affairs and/or Pharmacovigilance.
• Strong organizational and process management skills.
• Strong financial reporting experience and skills and understanding of business systems.
• Demonstrated project management capability.
• Preferably in-depth experience in drug development process over
• different stages, esp. clinical development and clinical operations.
• Highly effective communicator with strong influencing ability and communication skills.
• Demonstrated ability to function effectively and successfully in a complex global and multicultural environment.
• Ability to take personal responsibility and accountability
• Experience of leading and contributing to teams across cultures and geographies (if applicable).
• Experience in development and authorship of complex PV documents
• Experience of working across and building effective working relationships between functions.
• Organized, able to multi-task effectively.
• Fluency in English (written and verbal communication skills).
• Collaborative, team-oriented, flexible.
• Knowledge in Pharmacovigilance relevant regulations.

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