Qualified Person for Pharmacovigilance at Evolet Healthcare

Evolet Healthcare Pvt. Ltd. is an international, modern and dynamic outsourcing company that specializes in the field of contract manufacturing and marketing of pharmaceutical products. The Management of the company constantly monitors innovations in the pharmaceutical industry to keep up with the ever-increasing demands on pharmaceutical products to improve and enhance the quality of services irrespective of which part of the world the client comes from.
Evolet Healthcare Pvt. Ltd. has long-term contracts with manufacturers of pharmaceutical products, as well as with international pharmaceutical corporations and marketing companies that distribute its products in the markets of Asia, EU, CIS, Africa and Latin America.
Evolet Healthcare Pvt. Ltd. is looking for a highly qualified and motivated candidate for the position of “Qualified Person for Pharmacovigilance (QPPV)”. We have our corporate office in Gurgaon. For the better of our employees and their benefits, we offer a handsome salary package along with the lunch facilities.

Post: Qualified Person for Pharmacovigilance (QPPV)

Job Description
"The QPPV is responsible for:
• Establishing and maintaining/managing the Marketing Authorisation Holder’s (MAH’s) pharmacovigilance (PV) system
• Development and maintenance of the Master file of the pharmacovigilance system (PSMF), overseeing it’s content and maintenance, and ensuring the availability of the PSMF to Competent Authorities (CA)
• Having an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products for which the MAH holds authorizations
• Establishment and maintenance of a system that ensures that information about all suspected adverse events that have been reported to employees of the authorization holder are collected and united so that they are fully accessible to at least one place in the territory
• Acting as single contact point for the Competent Authorities (CA) on a 24-hour basis

Main duties:
The QPPV will perform the following activities on behalf of the Marketing Authorization Holder.

Responsibilities will include:
- Ensuring that the Marketing Authorization Holder has appropriate PV system in place
- Acts as a main PV contact point for the regulatory authorities on 24 hour basis
- Maintaining oversight of the PV system in all relevant aspects of including:
- SOPs
- Training
- Contractual arrangements
- Databases (awareness of validation status of the database, changes in database and need for revalidation)
- Compliance data regarding quality
- Audit/inspection plans and Corrective Actions Preventative Actions
- PV systems of local affiliates
- Ensuring that all PV processes are conducted in accordance with pertinent regulations
- Overseeing preparation and maintenance of PV System Master File
- Maintaining an overview of safety profiles and any emerging safety concerns of all Marketing Authorization Holder products
- Ensuring that the signal management process is in place in order to identify possible safety signals on Marketing Authorization Holder products
- Ensuring awareness and appropriate fulfilment of CA queries and commitments
- Development of Risk Management Plans
- Development of Periodic Safety Update Report (PSUR)
- Have input to the risk based audit of PV system is performed at pre-defined intervals and if justified instigate an audit for cause
- Managing members of the QPPV Office
- Carrying out continuous overall pharmacovigilance evaluation of the drug post marketing

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Candidate Profile
- As a QPPV must be a person with higher professional education and work experience in the corresponding profile of the industry, at least 2 years. Has medical practice experience
- Post-graduate training and/or ample work experience in pharmacovigilance and risk management (regulatory agency or industry)
- Technical knowledge of commercial drug safety databases
- Expert knowledge of the laws and regulations relevant to pharmacovigilance
- Marketing and medical information on Drug Company and the relevant therapeutic areas
- English at a level sufficient for business correspondence and participation in business activities
- Analytical approach to problem solving
- The basics of working in MS Office: Word, Excel, Power Point, Outlook.

Additional Information:
Experience: 2 Year
Education: M.Pharm/B.Pharm
Location: Gurgaon
Functional Area: Pharmacovigilance
Industry: Pharma/Biotech
Last Date: 30^th September, 2015