Dr. Reddy’s Hiring Head – Pharmacovigilance

Dr. Reddy’s Hiring Head – Pharmacovigilance

1 April, 2022

Head – Pharmacovigilance for India and EM.
Applications and references preferred to be sent from the below link.

Head – Pharmacovigilance (India & Emerging Markets) Hyderabad, Telangana, India Pharmacovigilance, QPPV, Emerging Markets@careers.drreddys.com

Any technical issues you face, profiles can be directed to ”Nareshkumar.g@drreddys.com

Job Description:

The Head of Pharmacovigilance (PV) India and Emerging Markets is responsible for ensuring India and Emerging Markets PV remains compliant with applicable local legislation through the oversight of on time delivery of end to end PV related activities.  An important part of the role of Head of PV India & EM is the communication and coordination of PV oversight with the contributing countries of the EM region, ensuring open and clear communication on PV issues and that local QPPVs and/or Responsible PV Persons have the appropriate access and input to the global PV system, and the ability to escalate regional/local safety issues.

Department:

CorporateOpen Positions:

1Skills Required:

Pharmacovigilance, QPPV, Emerging MarketsRole:

Responsibilities:

  • Maintain oversight of PV activities for the region, ensuring on time delivery of end to end PV activities, including submission of individual case safety reports and aggregate reports,and signal detection activities in accordance with local regulatory requirements.
  • Serve as the India and EM subject matter expert for pharmacovigilance, materiovigilance (devices) and cosmetovigilance (cosmetic) regulations and requirements and align with global activities and team of Dr Reddy’s as an organization.
  • Drive communication and collaboration on PV related matters with the individual countries of the region through regular leadership meetings, ensuring open and clear communication on PV issues and that local QPPVs and/or Responsible PV Persons have the appropriate access and input to the global PV system, and the ability to escalate regional/local safety issues.
  • Assist in the evaluation and interpretation of identified safety signals as required, and in collaboration with the Head of Medical Assessment.
  • Ensure the regional/local implementation of additional risk minimization measures in accordance with Company and regulatory requirements.
  • Work closely with local/regional Regulatory Affairs, Quality, Clinical Development and Medical Affairs personnel to ensure appropriate PV input to cross-functional activities for development and marketed products.
  • Oversee pharmacovigilance QMS and compliance activities for presentation at monthly compliance meeting and inclusion in monthly report as necessary.  Develop and implement appropriate regional and local PV procedural documents in alignment with global documents and processes.
  • Participate in the management of regional/local third party alliances, portfolio acquisitions and due diligence activities in collaboration with the Head of PV Operations and Head of Medical Assessment.  Contribute to the establishment and review of Safety Data Exchange Agreements with third parties and escalate any non-compliances with existing agreements
  • Ensure all required pharmacovigilance training is rolled out across the region for PV and non-PV personnel
  • Oversee and contribute to proposals for functional budget
  • Act as PV subject matter expert for internal and external audits and/or inspections

Relationship Management

  • Build relationships with key stakeholders, notably the PV responsibles in individual countries of the region
  • Work closely with the Head of PV Operations and the Head of Medical Assessment to ensure oversight of deliverables for the region
  • Define practices under the supervision of the Head of Regions and Global Head of Pharmacovigilance and support to implement the same
  • Actively participate in Regional PV Governance meetings to ensure key stakeholders are informed of safety updates for products in the region

Process Improvement / Standardization

•     Endorse the implementation of global standards for PV in the region

•       Identify areas of improvement and propose recommendations in functional reviews; develop and implement action plan for approved changes

Desired Skills & Competencies

  • Good working knowledge of regional and global regulations for pharmacovigilance
  • Demonstrates leadership within cross-functional team environment
  • Excellent teamwork and interpersonal skills
  • Good influencing skills and decision making
  • Fluent in English (written and spoken)

Location:

Hyderabad, Telangana, IndiaEducation/Qualification:

MBBSYears Of Exp:

15 to 20 YearsPosted On:13-Jun-2021Designation:

Head – Pharmacovigilance (India & Emerging Markets)

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