Glenmark Pharmaceuticals Hiring B. Pharm,M. Pharm In Pharmacovigilance
Glenmark Pharmaceuticals Released Job Openings On 23/12/2022. Glenmark Pharmaceuticals Limited is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977.Eligibility Criteria / Educational Qualification, Official Notification, Apply Online Form Link & Other Relevant Details for Glenmark Pharmaceuticals Recruitment 2022 are provided below. Interested and eligible candidates can submit application along with resume.
Vacancy Details:
Glenmark Pharmaceuticals Recruiting B. Pharm / M. Pharm Graduates with 08-12+ years of Experience for Assistant Manager – Pharmacovigilance (Signal Detection & Management) Position.Complete Details for the Assistant Manager – Pharmacovigilance (Signal Detection & Management) as follows.
Important Details :
- Location : Mumbai (All Areas)
- No of Vacancies:01
- Details of Salary: NA
- Opening date for online Application:23/12/2022
- 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
Job Description/Skills Required
1. Author drug safety reports
- Author all types of safety reports including DSURs, PADERs, PSURs, PBRERs, Addendum to Clinical Overview, Benefit-Risk reports)
- Generate high-quality reports within company and regulatory timelines
2. Contribute to the development and implementation of Risk Management Plans
- Generate high-quality Risk Management Plans for assigned clinical and marketed products within company and regulatory timelines
- Support the evaluation of effectiveness of risk minimization measures for assigned products
3. Perform signal detection and evaluation
- Evaluate information/data generated from the safety database, literature sources including data sources outside the ownership of PV (clinical trials, observations studies, preclinical data, epidemiology etc.) as well as external pre-evaluated information (innovator label reconciliation and regulatory requests, PRAC decisions)
- Presentation of analysed signals to the Glenmark Signal Management Team (SMT) and Human Safety Group (HSG) for assigned products
- Evaluate the potential clinical safety ramifications of product quality issues and make recommendations for actions
4. Lead or participate in cross-functional safety review teams for products in clinical development
- Active participation in leading safety issues for products in clinical development- additionally taking the lead for safety issues for products
- 5. Review and provide input into safety sections of study related documents
- 6. Respond to regulatory authority/healthcare professionals queries for assigned products
- 7. Review literature search results for ICSRs and articles for inclusion in safety reports
- 8. Liaise and collaborate with other GPV functions, international Glenmark affiliates and external business partners
- 9. Support product labelling activities, audits, inspection and CAPA management relating to SERM activities
- 10 .Support assessment and implementation of regulatory intelligence findings that impact SERM activities
Comments
Post a Comment