Work Opportunity as a Medical Writer I at Parexel – Apply Now

0
174
WhatsApp D. Pharma Group Join Now
Telegram D. Pharma Group Join Now
Telegram Group Latest Pharma Jobs Join Now
Telegram B. Pharma Group Join Now
Telegram Medicine Update Group Join Now
WhatsApp B. Pharma/ GPAT Channel Join Now

Embark on a transformative career journey with Parexel! Your gateway to exciting career opportunities begins here as we invite talented individuals to join our team as Medical Writer I in the vibrant city of Mohali, India. At Parexel, we are at the forefront of advancing clinical research, prioritizing patient safety, and actively shaping the landscape of life-changing therapies.

Medical Writer I

As a Medical Writer I, you will play a crucial role in translating complex scientific information into clear, concise, and compelling documents. This position offers a unique blend of scientific expertise and communication skills, making it an ideal opportunity for those passionate about contributing to groundbreaking advancements in healthcare.

Job Title

Medical Writer I

No. of Posts

01 (UR)

Qualification

1. Science/Medicine degree: The minimum qualification required is a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics, etc.).

2. A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing involving patient exposure in a hospital-based environment would be an advantage.

Knowledge

1. Relevant experience in Regulatory/Pharmacovigilance or related field is desirable.

2. Good knowledge of medical terminologies.

Job Purpose

Responsible for the management of scheduled and unscheduled aggregate reports, including but not limited to Periodic Safety Reports (PSRs) such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Risk Management Plan (RMP), Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs), as well as preparing a document of comparison between local and global labeling documents (if applicable) and checking International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and signal detection and management (where applicable).

 

Key Accountabilities:
Aggregate Reports:
1. Preparing/updating/merging RMPs/Company Core-RMPs (CC-RMPs), preparing a health authority response document along with RMS update in accordance with client requirements/conventions and SOPs.
2. Managing scheduled and unscheduled aggregate reports, including but not limited to PSURs, PBRERs, ACOs, SASRs, PADERs, DSURs, ARBE report, Safety statements, HHE, DSR, CO, SER, INDARs, comparison document between local and global labeling document, and checking of INNs for inclusion in a PSR as per client requirements and conventions.
3. Conducting critical appraisal and systematic review of literature, focusing on background epidemiology for inclusion in drug Safety Reports and RMPs.
4. Providing input and developing literature search strategies for the epidemiology section of safety reports.
5. Applying epidemiological methods and calculations to data available in literature to support the background rates of the issues under evaluation for the safety reports.
6. Generating Line Listings for submissions and identifying discrepancies for resolution.

Clinical Study Report Narratives:
1. Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client.
2. Ensures appropriate medical cohesiveness and assessment in accordance with client’s and Parexel’s conventions/guidelines and Standard Operating Procedures.
3. Performs quality checks on drafted narratives as required.
4. Assists in compilation and formatting of narrative deliverables.

Signal Detection and Management:
1. Performs signal detection review and analysis (qualitative and quantitative) from various sources.
2. Responsible for end-to-end signal management process in collaboration with the safety science.
3. Conducts/supports signal detection and evaluation activities according to SOPs and guidelines.

General:
1. Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures, SOPs, and international drug safety regulations.
2. Ensuring all work is complete and of high quality.
3. Attending internal, drug safety, and project-specific training sessions.
4. Preparation for, participation in, and follow-up on audits and inspections.
5. Maintaining an awareness of global regulatory reporting obligations.
5. Organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
6. Delegating work as appropriate to Associate Medical Writer.
7. Striving to enhance client satisfaction based on feedback.
8. Serving as the primary client contact, liaising and collaborating with the relevant function at the client’s end.
9. Evaluating and incorporating reviewer comments in draft reports.
10. Mentoring new recruits in the team if required.
11. Archiving source documents and relevant emails as required.
12. Responding to clients/customers in a timely manner.

Skills:
1. Analytical and problem-solving skills.
2. Excellent interpersonal, verbal, and written communication skills.
3. Excellent organizational and prioritization skills.
4. Ability to work collaboratively and effectively in a team environment.
5. Client-focused approach to work.
6. Ability to evaluate data independently and draw conclusions.
7. Flexible attitude with respect to work assignments and new learning.
8. Ability to manage multiple tasks with enthusiasm and prioritize workload with attention to detail.
9. Fluent in written and spoken English.
10. Computer proficiency, IT skills, and familiarity with web-based applications and the MS Office suite.

Company: Parexel
Location: India-Mohali
Time Type: Full-time
Job Requisition ID: R0000017796

APPLY NOW

<<<<<<<<<<<<<MORE JOBS>>>>>>>>>>>>>>>>

Recruitment of Pharmacists (28 Posts) under Medical Service Recruitment Board (MRB) More Info..
Recruitment of Pharmacist Grade-II at APWP Hospitals – Apply Now More Info..
Work Opportunity as a Medical Scribe at OG Healthcare – Freshers can Apply More Info..
Career as a Pharmacovigilance Officer at PrimeVigilance – Apply Now More Info..
Career Opportunity as Quality Assurance Executive at Zentiva More Info..
Opportunity as a Quality Assurance Officer at Herbalife International India Pvt. Ltd. More Info..
NHSRC Hiring: Junior Consultant for Community Processes & Comprehensive Primary Healthcare – Apply Now More Info..
Walk-in Interview as a Pharmacist at Chennai Port Authority Hospital More Info..
Opportunity as a Technical Assistant at ICMR-National Institute of Cancer Prevention and Research (NICPR) – Apply Now
More Info..
Vacancy for Pharmacist under District Health Family Welfare Samity & Office – Apply Now More Info..
Pharmacist Vacancy under National Health Mission (NHM) Thiruvananthapuram More Info..
Vacancy for Pharmacist at Bhavnagar Zilla Panchayat under NHM More Info..
Opportunity as a Junior Research Fellow (JRF) at Indian Institute of technology (IIT) Ropar More Info..
Recruitment of Drug Inspector (03) under Himachal Pradesh Public Service Commission (HPPSC) -Apply Now More Info..
Opportunity as a Patient Safety Specialist-2 at Alcon More Info..
Thermo fisher Scientific is hiring Safety Specialist-III – Apply Now More Info..
Join the Biocon KGI Certificate Program in Biosciences: A Path to Career Excellence More Info..
Walk-in Interview as a Pharmacist (02 Post) under Central Government Health Scheme – Apply Now More Info..
Recruitment of Pharmacist (10 Post) at Health Medical & Family Welfare Department – Apply Now More Info..
Unlock Your Career Potential: Jr. Pharmacist Opportunity at Christian Medical College – Apply Today More Info..

 

<<<<<<<<<<<<<JOIN US>>>>>>>>>>>>>>>>

Subscribe our PHARMACY INDIA Youtube Channel for more Pharma Updates Click Here
Follow us on Instagram Click Here
Download PHARMACY INDIA MOBILE APP from Google Play Store  Click Here
Follow us on LinkedIn Click Here

LEAVE A REPLY

Please enter your comment!
Please enter your name here