Troikaa Pharmaceuticals Released Job Openings On 05/09/2022.Troikaa is a young and fast growing system oriented pharmaceutical company. Troikaa is recognized as a discovery company, manufacturing innovative products based on varied Novel Drug Delivery Systems. The company has developed through in-house R&D, unique patented technology platforms for intra-oral, parenteral, sustained release and topical drug delivery.Â
Vacancy Details:
Troikaa Pharmaceuticals Recruiting M.Pharma Candidates with 10 to 14 years of Experience for Manager / Sr. Manager – Pharmacovigilance Position.Complete Details for the Manager / Sr. Manager – Pharmacovigilance as follows.
Important Details :
- Location :Ahmedabad( Bodakdev )
- No of Vacancies:NA
- Details of Salary:₹ 9,00,000 – 14,00,000 P.A.
- Opening date for online Application: 05/09/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Related Job : Pfizer Hiring For Safety Officer – Pharmacovigilance RoleÂ
Job Description/Skills Required
Overall knowledge about Pharmacovigilance system functioning, conducting and supervising
regular Pharmacovigilance processes
• Collection, Processing and Reporting of Individual Case Safety Report that includes:
- Collection and verification of Individual Case Safety Report
- Case creation and data entry in safety Database
- Coding using MeDRA and WHO – DD
- Quality review
- Case Narrative Writing
- Generation of XML format
- Regulatory Submission
• Scientific and Medical literature search for safety information and reporting to regulatory:
- Worldwide literature search using various search engines
- Valid ICSRs shall be processed through safety database after quality review and medical review and regulatory submission within the stipulated time frames
- Knowledge about exclusion criteria for the submission of ICSRs published in the medical literature
• Preparation / review of Periodic Safety Update Report (PSUR)
• Preparation, Submission and Implementation of Risk Management Plans
• Signal Management includes:
- Signal Detection & Validation
- Signal Analysis and Prioritization
- Signal Assessment
- Recommendation for action
• Preparation / review of SDEA (Safety Data Exchange Agreement) for selected products
• Preparation of Pharmacovigilance Master File and regular updates
• Preparation of Pharmacovigilance Plan and regular updates
• Preparation / review and updates of SOPs
• Knowledge regarding various regulatory guidance and ensure compliance
• Periodic review of the database for potential safety issues
• Support the setup and implementation of Pharmacovigilance activities for research studies
at both local and central level, including staff training
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