Safety Writer

2-5 years years

Preffered by Company

Hyderabad

10 June 3, 2024

Job Description

Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Safety Writer
Job ID: JOB006
Employment Type: Full-Time
Location: Hyderabad
Experience Required: 2 - 5 Years

Job Description: The Safety Writer will be responsible for preparing and reviewing aggregate reports according to guidelines and work instructions.

Essential Functions:

Author and review Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports, ACO, DSUR) for submission to local and other health authorities.
Author and review Risk Management Plans (RMPs) as part of regular pharmacovigilance activities.
Author and Quality Review of Signal Management Reports.
Perform literature searches and validity checks for aggregate reports.
Manage and reconcile relevant process trackers.
Serve as a Subject Matter Expert (SME), training and mentoring team members.
Extract and validate data (RSI, sales, previous reports, RMP, signals).
Generate Line Listings (LL) from the safety database.
Provide reliable support for high-priority ad-hoc activities.
Interact with client personnel to resolve issues related to Aggregate reports in accordance with clients’ policies.
Ensure that deliverables comply with relevant regulatory requirements and are delivered within agreed timelines.

Qualifications:

PhD, M-Pharmacy/B-Pharmacy, or Doctor of Pharmacy (PharmD) from a PCI recognized university or college.
Preferred: 2-5 years of experience in authoring Aggregate Reports.
Proficient in computer operations and keyboarding skills.
Proficient with Microsoft Office Suite (Outlook, Word, Excel).
Strong verbal, written, and interpersonal communication skills.
Excellent organization and prioritization skills, capable of multitasking.
Flexible, able to adapt to fluctuating business priorities.
Willingness to occasionally work extended and/or flexible schedules to meet client requirements.

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Safety Writer

Job Description

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