Manager - Pharmacovigilance & Quality Compliance ~ PHARMANAUKRI.IN

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)

Summary

Experience:

6 - 10 Years

Location:

Gurgaon

Compensation:

Rupees 9,00,000 - 12,00,000

Education:

UG - B.Pharma - Pharmacy,B.Sc - Any SpecializationPG - M.Pharma - Pharmacy,M.Sc - Any Specialization

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Bio/Pharma Informatics-Associate/Scientist

Functional Area:

Healthcare, Medical, R&D

Posted Date:

28 Apr

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.

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.

Primary Activities:

Report all Serious Adverse Reactions (SARs) to the internal Drug Safety and Risk Management (DSRM) and Regulatory Agencies as applicable.

Ensure tight regulatory timelines are met for Adverse Event (AE) reporting.
Submit local and global AE information to Regulatory Agencies, as applicable.
Respond to safety queries (in collaboration with Head Quarters and Medical Affairs) raised by

investigators, Ethics Committees (ECs) and prescribing physicians.
Ensure that systems and procedures are in place for the company to meet regulatory, legal

and corporate requirements for AE reporting.
Work closely with global Compliance organization to monitor Pharamcovigilance compliance

of Contract Research Organizations (CROs)
Deliver training for all study related PV activities to Affiliate personnel, CRO/SMO staff.
Train sales and marketing teams on Pharmacovigilance reporting.
Maintain audit ready files for regulatory inspections and HQ audits.
Ensure that all SOPs applicable for Clinical Research are developed and implemented.
Enable Quality Compliance for all clinical research activities undertaken by the Clinical Operations group. This may include but not be limited to CRO qualification, on site audits, audits of the CRO facility during study conduct, audit of essential documents maintained at subsidiary and clinical study report review. This activity is performed in line with and reporting to the Global Quality Function.
Manage regulatory process to ensure effective and timely commercial filings and approvals of

new products, product variations (inclusive of changes in CMC, labeling) and renewals.
Establish strong working relationships with internal and external stakeholders
Liaise with key experts and opinion leaders in Industry groups and Regulatory Agencies, in order to remain conversant with evolving PV regulations and methodologies.

Keywords: Pharmacovigilance,QA, QC,Regulatory affairs

Company Profile

Our client is a wholly owned susidiary of a US MNC . The company is a R&D based leading biotechnology company .The company provides to its employees, an exciting and invigorating place to work, an ambitious company where courageous innovation is encouraged and expected.
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