29/07 sathish
Talent Acquisition at BVR People Consulting

Views:280 Applications:22 Rec. Actions:Recruiter Actions:2

Drug Safety Physician - Hospital - MBBS/BHMS/BAMS (1-6 yrs)

Mumbai Job Code: 7114

Role: Drug Safety Physician - Aggregate Reports

Education: MBBS/ BHMS/ BAMS

Location: Vikhroli, Mumbai

Experience: 1-5 Years

Job Responsibilities:

1.Prepares and conducts peer review of periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.

2.Conducts literature reviews and provides assessment and analysis of published literature.

3.Maintains current awareness of safety issues on Company products through ongoing monitoring & literature review demonstrating scientific skills in the research, analysis, and interpretation of safety data. Informs management of trends and prepares the PLCM Unplanned Change Event Summary Report for the Drug Safety Committee.

4.Assists in the preparation/review of Risk Management plans.

5.Develops and maintains SOPs, Safety Data Exchange Agreements with business partners, and training documents and tracks compliance of internal and external global partners involved in drug safety reporting.

6.Acts as a delegate for Group leader, GPV.

7.May provide input and feedback to departmental process improvement strategy discussions

8.Contributes to the creation and promotion of an environment of teamwork ensuring excellence in customer service through the timely delivery of quality drug safety data.

9.Liaises regularly and develops a strong working relationship with external partners and international Company affiliates and demonstrates corporate values in the performance of work and in all interactions with others.

10.Maintains user-level knowledge of Oracle ARGUS and MedDRA terminology.

11.Interacts with other internal departments when necessary.

12.Prepares responses to slightly more complex queries, and requests for safety information from the internal customer (RA, QA, NPD project teams etc.).

13.Contributes to the interpretation of PV regulations and applies sound decisions related to regulatory guidelines and policies.

14.Shows initiative to remain current on new PV regulations and international guidelines and seeks guidance from Group Leader and management to enhance knowledge.

15.Performs all work in accordance with all established ICH guidelines, regulatory compliance and safety requirements and maintains current knowledge on all relevant Pharmacovigilance regulations.

16.Works as a member of a team to achieve all outcomes.

17.Performs all work in support of our Corporate Values of Pride, Accountability, Integrity, and Diligence; Demonstrates strong and visible support of our values.

18.Performs all work in accordance with all established regulatory and compliance and safety requirements.

19. All other duties as assigned.

Interested candidates kindly share your profile 

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