- Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including 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 document of comparison between local and global labeling document (if applicable) and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and signal detection and management (where applicable).
- Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions, tests electronic submissions gateways, and tracking compliance monitoring of submissions in accordance with client/international conventions
- Responsible for preparing the narratives associated with the client's/sponsor's products from clinical trials for Clinical Study Reports (CSRs) or in order to support any health authority requests in accordance with regulatory and client's/sponsor's requirements.
- Imparting trainings to the new starts during the induction sessions and the team as required.
- Demonstrating document leadership: communicating content requirements, coordinating and conducting interdepartmental team review of draft and final documents, scheduling and leading/facilitating authoring team meetings to agree on expectations, evaluate progress on tasks, identifying issues and facilitating resolutions, managing/driving the timeline, and advance document development to approval
- Striving to enhance client's satisfaction based on feedback provided by the client
- Helping in management of process related queries at user level.
- Acting in the capacity of lead, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues.
- Project management of contractual and financial aspects, as necessary with guidance from management.
- Identifying areas of concern within the team and raising the issues with project manager
- Preparing/Updating/Merging RMPs/Company Core-RMPs (CC-RMPs), preparing health authority response document along with RMS update in accordance with client requirements/conventions and SOPs
- Managing scheduled and unscheduled aggregate reports including but not limited 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), comparison document between local and global labeling document (if applicable)and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and conventions and SOPs
- Conducting critical appraisal and systematic review of literature with a focus on background epidemiology, specifically information on the incidence, prevalence and risk factor in patient populations, for inclusion in drug Safety Reports and RMPs
- Providing input and developing literature search strategies for the epidemiology section of safety reports
- Applying epidemiological methods and calculations to data available in literature to support the background rates of the issues under evaluation for the safety reports
- Performing aggregate report compliance activities including quality review to check the data/facts and internal consistency across various type of aggregate reports including but not limited to PBRERs, Ad hocs, HHEs, LJDs, tables, RMP, Pharmacovigilance System Master File (PSMF) document (as applicable)
- Generating Line Listings for submissions/ to identifying discrepancies and ensuring resolution of the discrepancies
- Distribution of final reports to the stakeholders including partners, affiliates and submission to health authorities, according to the agreed timelines, distribution lists and email templates (as required)
- Scheduling and coordinating meetings/ Drafting meeting agenda and minutes/Tracking action items and soliciting follow-up for open issues
- Coordinates and liaises with the members of Study Management Team (SMT)/Study In-charge or equivalent, to discuss the narrative template development process, narrative categories and review of the narratives (as required)
- Serves as primary client contact for narrative writing for an assigned study, agreeing/negotiating deliverable timelines, and addressing/resolving any narratives related issues (as required)
- Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client and ensures their appropriate medical cohesiveness and assessment in accordance with the client's and Parexel's conventions/guidelines and Standard Operating Procedures
- Performs quality checks on the drafted narratives as required
- Ensures the work is complete and of high quality, including final quality control checks, compilation and formatting.
- Provides CSR narrative review support to the SMT where requested
- Build and maintain collaborative relationships with SMTs for an efficient, productive, and professional working relationship (as applicable)
- Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc.
- Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO
- Conduct/support signal detection and evaluation activities according to SOPs and guidelines
- Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client's guidelines, procedures and SOPs, and international drug safety regulations
- Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting
- Maintaining a good working knowledge of the assigned Clinical studies for narratives
- Attending/conducting internal, drug safety and project specific training sessions
- Imparting trainings to the new starts during the induction sessions and the team as required.
- Demonstrating document leadership: communicating content requirements, coordinating and conducting interdepartmental team review of draft and final documents, scheduling and leading/facilitating authoring team meetings to agree on expectations, evaluating progress on tasks, identifying issues and facilitating resolutions, managing/driving the timeline.
- Preparation for, participation in, and follow up on audits and inspections
- Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
- Striving to enhance client's satisfaction based on feedback provided by the client
- Helping in management of process related queries at user level.
- Acting in the capacity of lead, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects, as necessary with guidance from management.
- Liaising and collaborating with the relevant function at the client's end to facilitate the delivery of high-quality work
- Evaluating and incorporating reviewer comments in draft reports and liaising with relevant contributors for resolution of comments
- Identifying areas of concern within the team and raising the issues with project manager
- Mentoring new recruits in the team, if required
- Archiving the source documents and relevant emails as required
- Responding to clients/customers in a timely manner
- Analytical and problem-solving skills
- Excellent interpersonal skills
- Excellent verbal / written communication skills
- Excellent organizational and prioritization skills
- Ability to work collaboratively and effectively in a team environment
- Client focused approach to work
- Ability to evaluate data and draw conclusions independently
- A flexible attitude with respect to work assignments and new learning
- Ability to negotiate on behalf of the department to ensure resources, timelines and expectations are aligned
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Fluency in written and spoken English
- Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
- Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services.
- Provides departmental expertise and perspectives to promote prospective business opportunities.
- Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
- Typing and transcription accuracy
- Awareness of global culture
- Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field.
- Good knowledge of medical terminologies
- Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)
- A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage
-
Medical Writer
3 days ago
medivisual healthworld Mohali, IndiaWe have requirement of a Medical Writer. Having 3-4 years of experience in the same. · **Responsibilities** · - Comprehensive writing skills with good command of written and spoken English. · - Content development for web pages, blogs, articles, product descriptions, social media ...
-
Medical Content Writer
3 days ago
Planet Ayurveda Private Limited Mohali, India**Who can Apply? ==>** · - _Physiotherapist_ · - _BDS_ · - _Veterinarian_ · - _MA English_ · - _B.Sc. Botany_ · - _M.Sc. Botany_ · - _B. Sc. Zoology_ · - _M. Sc. Zoology_ · - _B. Pharma_ · - _M. Pharma_ · **Job Summary ==>** · Planet Ayurveda Pvt. Ltd. is offering you a great opp ...
-
Medical Content Writer
1 week ago
Planet Ayurveda Pvt. Ltd. Mohali, India**Who can Apply? ==>** · - _Physiotherapist_ · - _BDS_ · - _Veterinarian_ · - _MA English_ · - _B.Sc. Botany_ · - _M.Sc. Botany_ · - _B. Sc. Zoology_ · - _M. Sc. Zoology_ · - _B. Pharma_ · - _M. Pharma_ · **Job Summary ==>** · Planet Ayurveda Pvt. Ltd. is offering you a great opp ...
-
Medical Content Writer
2 days ago
medivisual healthworld Mohali, India**Responsibilities**: · - Conduct in-depth research to gather reliable and up-to-date medical information from credible sources. · - Write clear, concise, and engaging medical content for websites, blogs, articles, whitepapers, social media, and other platforms. · - Generate crea ...
-
Medical Content Writer
3 days ago
pharmapick Mohali, IndiaJob Responsibilities: · - Able to extract information from journals and translate clinical data into succinct/engaging writing · - Able to communicate scientific or medical information in a clear and concise manner · - Ability to interpret and present clinical data and other comp ...
-
Medical Content Writer
1 week ago
Talent Recruitment Chandigarh, India**Hello** · **Greetings from Talent Recruitment** · **Hiring Content Writer(IT Company)** · **Work from Office** · **Location**:Mohali** · **Position Overview**: · **OUR Client **is seeking an experienced Content Writer to join their team. As a Content Writer, you will be respons ...
-
Social Media Content Writer/creator
4 days ago
APPWRK IT Solutions Mohali, India**Are you Looking For Best Social Media Content Writer Jobs in Mohali?** · Here we are Hiring For the Job of** Social Media Content Writer/Creator** and your roles and responsibilities at **APPWRK IT Solutions Mohali** would be as mentioned below: · - Writing, editing and publish ...
-
Content Writer
4 days ago
APPWRK IT Solutions Mohali, India**Content Writing Job at APPWRK (Mohali): Roles and Responsibilities**: · **Are You Looking For Best Content writer Jobs in Mohali?** · Here we are Hiring For the Job of** Content Writers** · At **APPWRK IT Solutions (Mohali)**:your **roles and responsibilities** would be as foll ...
-
SEO Content Writer
4 days ago
APPWRK IT Solutions Mohali, India**Are You Looking for Best SEO Content Writer Jobs in Mohali?** · Here we are Hiring for the Job of** SEO Content Writers**: · At **APPWRK IT Solutions Mohali**: Your roles and responsibilities would be as mentioned: · - Create **content marketing** campaigns to drive leads and s ...
-
Content Writer
2 days ago
Primotech Mohali, Punjab, India**Job Title: Content Writer** · **Shift Timings: 10 am to 7pm** · **About Us**: · We as Primotech are as an IT Global Solutions company. We've been delivering software · development and IT projects from several big enterprises to small and medium-sized · businesses. We blend agil ...
-
Content Writer- Fresher
1 day ago
Primotech Mohali, India**Job Title: Content Writer** · **Fresher** · **Shift Timings: 10 am to 7pm [Flexible shift]** · **About Us**: · We as **Primotech **are as an IT Global Solutions company. We've been delivering software development and IT projects from several big enterprises to small and medium- ...
-
Content Writer
9 hours ago
Medivisual Healthworld Mohali, IndiaWe are seeking a talented and motivated Content Writer to join our team and create engaging and informative content for our blogs. As a Content Writer, you will be responsible for researching, writing, and editing high-quality articles related to various personal care topics. We ...
-
Content Writer
4 days ago
Primotech Mohali, India**Job Title: Content Writer** · **Experienced · - 2+ years** · **Shift Timings: 10 am to 7pm [Flexible shift]** · **About Us**: · We as **Primotech **are as an IT Global Solutions company. We've been delivering software development and IT projects from several big enterprises to ...
-
Content Writer
2 days ago
Primotech Mohali, India**Job Title: Content Writer** · **Experienced · - 1-2 years** · **Shift Timings: 10 am to 7pm [Flexible shift]** · **About Us**: · We as **Primotech **are as an IT Global Solutions company. We've been delivering software development and IT projects from several big enterprises to ...
-
Content Writer
1 week ago
Primotech Mohali, Punjab, India**Job Title: Content Writer** · **Shift Timings**:10 am to 7pm · **About Us**: · We as Primotech are as an IT Global Solutions company. We've been delivering software development and IT projects from several big enterprises to small and medium-sized businesses. We blend agile met ...
-
Social Media Coordinator
3 days ago
LOGITRADE BPO SOLUTIONS PVT LTD Mohali, IndiaWALK IN INTERVIEW WORK FROM OFFICE ONLY · Should be comfortable working in **Night Shifts.** · **About Logitrade**: · We are a logistics company based in Canada with inland and interstate trucking at its heart. We are in close networks with Canadian Rails and Ports and pick up a ...
-
Female Healthcare Counselor(Night Shift)
1 day ago
DIET TIFFIN PRIVATE LIMITED Chandigarh, India**Dietitian Shreya is a Certified Clinical Nutritionist, an expert in Diabetes Management, Weight Management, and Hormonal Imbalance, and is also an Author/Freelance and Writer (Health & Lifestyle Nutrition).** · **Responsibilities**: · 1. Keep strong coordination with existing c ...
-
Female Healthcare Counselor(Wfh)
1 week ago
DIET TIFFIN PRIVATE LIMITED Patiala, India**Dietitian Shreya is a Certified Clinical Nutritionist, an expert in Diabetes Management, Weight Management, and Hormonal Imbalance, and is also an Author/Freelance and Writer (Health & Lifestyle Nutrition).** · **Responsibilities**: · 1. Keep strong coordination with existing c ...
-
Female Healthcare Counselor
1 week ago
DIET TIFFIN PRIVATE LIMITED Khanna, India**Dietitian Shreya is a Certified Clinical Nutritionist, an expert in Diabetes Management, Weight Management, and Hormonal Imbalance, and is also an Author/Freelance and Writer (Health & Lifestyle Nutrition).** · **Responsibilities**: · 1. Keep strong coordination with existing c ...
Senior Medical Writer - Sahibzada Ajit Singh Nagar, India - Parexel
Description
When our values align, there's no limit to what we can achieve.
Job Purpose:
Key Accountabilities :
Accountability
Supporting Activities
Aggregate reports
Clinical Study Report Narratives
Signal Detection and Management
General
Skills:
. Knowledge and Experience :
Education:
