Drug Safety Associate
- Samrat Job Point
- 6 to 11 Yrs
- Multi-City, India
- 3 years ago
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Job Description
Job Description Drug Safety Associate:
Skills Required:
o Basic competence with medical and therapeutic terminology.
o Capable to work independently but guided by documented procedure, with appropriate support
o Ability to work effectively as part of a team
o Understanding of patient safety regulatory obligations.
o Familiarize with regulatory and Pharmacovigilance guidelines and its terminology
o Deliverable in assigning the work and tasks within established timelines
o Manage to handle urgent calls
Responsibilities:
o Attend calls from people requiring medical care/who have taken sponsors medication in a
trial/post-marketing exposure to the drug and provide information as needed.
o Provide call handling training to the newly hired resources
o Training on SOPs and Workflow instructions to the newly hired resources
o Understand the requirements of the callers and provide precise information
o Provide QC support for the MICC
o Thorough understanding on use of FAQs
o Complete case entry including case narrative writing, coding from the MedDRA dictionary and
WHO drug dictionary as per applicable SOPs and Client requirements.
o Manage product-specific inquiries/medical inquiries, product complaints, AEs/SAEs calls, legal
complaints, call processing per SPG, SOPs and other related guidelines.
o Respond to web-based and written inquiries from Health Care Professional members and
consumers concerning the safety and effective use of all products marketed in a timely manner.
o To identify and retrieve relevant data and information appropriate to answer the information
requested
o Identify clinically relevant information and preparation of follow up request as needed.
o Receive, review and process Drug Safety information based on regulations and conventions
o Manage workload under the direction of Team Lead
o Act as a Subject Matter Expert
o Perform/Assist in documenting RCA and CAPA
o Comply with the processes and policies laid out for information security and responsible for using
the organizations information assets in accordance with the Acceptable Use Policy in ISMS
o Notify the supervisor or Information Security officer of any security breaches/incidents.
o Any other responsibilities including cross-functional assignments delegated by the organization to
fulfill business needs
Preferred Education: Bachelor in Health Discipline
Preferred Experience: 0 2 years industry drug safety or clinical research experience.
Special knowledge needed: MICC Requirements and Medical terminology
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Bio Tech / R&D / Scientist
Functional Area: Not Applicable
Role/Responsibilies: Drug Safety Associate
Contact Details:
Company: Samrat Job PointLocation(s): Multi-City, India
Samrat Job Point
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