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Senior Associate / Assistant Manager @ Evolet Healthcare

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 Senior Associate / Assistant Manager

Job Description

  • Coordination of pharmacoivigilance team for routine allocation, data collection and sharing reports with HOD and other affiliate representatives
  • Support in ensuring overall project management
  • Preparation of Aggregate Reports
  • Development of Periodic Safety Update Reports (PSURs)
  • Development of Risk Management Plans (RMPs) and other safety reports
  • Assist HOD for the preparation of Pharmacovigilance System Master Files (PSMFs), Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Service Agreements with business partners
  • Assist HOD in departmental Business Continuity Planning and implementation
  • Development, review and update of departmental Standard Operating Procedures (SOPs) and Working Instructions (WIs).
  • Preparation of training material and training of pharmacovigilance personnel in the obligations of pharmacovigilance for the marketed products
  • Track and measure quality performance of various pharmacovigilance department activities
  • Establish and maintain a high level of familiarity with the company procedures and applicable local and international pharmacovigilance regulations and guidance

Required Candidate profile

  • Preferably 2 to 4 years' experience
  • Candidate should be B Pharm and M. pharma
  • Have analytical skills;
  • High level of responsibility;
  • Ability to work under defined deadlines;
  • Strong organization and verbal/written communication skills;
  • Good working knowledge of MS Office (Word, Excel, Power point);
  • Excellent writing and presentation skills in English.

Job Classification

Industry: Pharma, Biotech, Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: R&D
Role: R&D
Employement Type: Full time

Education

Under Graduation: B.Pharma in Pharmacy
Post Graduation: M.Pharma in Pharmacy
Doctorate: Doctorate Not Required, Any Doctorate in Any Specialization

Contact Details:

Company: Evolet Healthcare Pvt.ltd.
Location(s): Noida, Gurugram
Website: http://www.evolet.in

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Keyskills:   Project Management Surveillance External Audit Business Continuity Planning Data Collection Risk Management Standard Operating Procedures Information System

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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 e...