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Monday, May 31, 2010

Manager - Pharmacovigilance & Quality Compliance Regulatory

Job Description

This is a senior role within the Regulatory and Compliance group with primary responsibility for leading Pharmacovigilance reporting and Quality Assurance activities. In addition, this role may entail certain responsibilities related to Regulatory planning and operations. Strong functional industry experience, working for a leading Pharma company in India, combined with effective communication and project management skills within a cross functional and matrix setting will be essential for success.


6 - 10 Years
Rupees 9,00,000 - 12,00,000
UG - B.Pharma - Pharmacy,B.Sc - Any SpecializationPG - M.Pharma - Pharmacy,M.Sc - Any Specialization
Industry Type:
Pharma/ Biotech/Clinical Research
Bio/Pharma Informatics-Associate/Scientist
Functional Area:
Healthcare, Medical, R&D

Desired Candidate Profile

  • Advanced graduate degree (MSc., Ph.D., other) from a leading Institute in a life science /health care or related discipline (biology / pharmacy/ pharmacology / biomedical sciences)
  • 6+ years of functional experience in regulatory affairs working for a leading Pharma or Biopharma company in India with experience in managing affairs with the CDSCO offices
  • Strong understanding of GCP and Indian Regulatory requirements for conduct of clinical research
  • 2+ years experience in a QA environment to demonstrate competency in the role.
  • Computer proficiency in Microsoft Office suite and MS Project
  • Highly developed verbal and written communication skills.
  • Well organized with strong project and time management skills.
  • Self-motivated to take initiative and follow through even when there is considerable ambiguity
  • Demonstrated track record of working in a matrix and cross-functional environment in a

    multinational company.  
  • Specialist Knowledge (Pharmacovigilance and Quality Compliance Areas):
  • Have a good grasp of the subject matter and a range of operational issues. Keeps selfupdated on new developments and methods. Continuously expands his/her knowledge base. Pays attention to detail.

Planning and Organizing / Self management:
  • Anticipates constraints, work scheduling and mobilizes efforts so as to achieve the targets/goals. Is organized and systematic.

Listening / Summarizing:
  • Collects, interprets and shares information effectively. Interacts, liaises and builds relationships with a diverse range of personnel both internal and external to the organization.
Problem Solving Attitude:
  • Overcomes obstacles through systematic analysis and informed decision-making. Seeks all relevant information and finds the optimal solution. Have a collaborative attitude, and can lead a cross-functional team.

Improvement Orientation:
  • Keeps own skill set up to date and is proactive in ensuring the implementation of new and better ways of achieving desired objectives. Ensures that learning is shared and that quality is maintained and improved upon.

Influencing and Persuading:
  • Makes an impact and puts his/her ideas and views across clearly. Establishes credibility, gains acceptance and converts resistance to acceptance.

Integrity/ Drive:
  • Internalizes the company’s philosophy and core values. Is committed to the job and works hard for the long term good of the organization. Takes on responsibility and accepts  challenges.

Company Name:
US Pharma MNC
Executive Name:
Mr. Vijay
Talent Network India
239,Mega Mall,
DLF Phase -4,Gurgaon
GURGAON,Haryana,India 122001


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