- Write and review various safety reports for global regulatory submissions, including but not limited to Annual Reports, Periodic Safety Update Reports, and Development Safety Update Reports.
- Author and review Risk Management Plans (RMPs), adhoc reports, and medical device reports.
- Draft responses to health authority questions or feedback and collaborate with cross-functional stakeholders.
- Conduct trainings for peers and junior team members and provide shadowing opportunities.
- Author/review manuscripts, abstracts, and posters for conferences.
- Perform/review signal detection activities and author signal reports.
- Act as a writing coach, devise training programs, and author/review SOPs/WIs/process documents.
- Coordinate activities related to report writing across a team of writers, if applicable.
- Assist in estimation of resource requirements and responding to Requests for Proposals (RFPs).
- Internal and external communication and coordination to obtain required inputs.
- Create and update labels, review literature searches, and perform routine surveillance.
- Implement and promote consistent, efficient, and quality processes to meet timelines and deliverables.
- Ensure compliance with regulatory requirements and maintain a culture of high customer service.
- Bachelor of Pharmacy degree
- 7 to 11 years of experience in pharmaceutical regulatory writing
- Expert proficiency in English language
- Strong problem-solving skills and ability to think creatively
- Commitment to diversity, inclusion, and equal opportunity employment
-
Thepharmadaily LLP is looking for Safety Writer to join our dynamic team and embark on a rewarding career journey · Develop safety guidelines and procedures. · Write and update safety manuals and documentation. · Conduct research on safety regulations and best practices. · Collab ...
Mumbai Full time1 day ago
-
Key responsibilities include: · Perform data collection for report planning and strategy development. · Write safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and more. · Conduct quality review of safety reports prepared ...
Mumbai Full time1 day ago
-
Report Writing: Write various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and Risk Management Plans. Author subject narratives for adverse drug reactions and serious adverse events. · Quality Control: Perform quali ...
Mumbai3 days ago
-
Responsible for the preparation and review of aggregate safety, risk management, and signal detection documents. · ...
Mumbai, Pune1 month ago
-
This position involves preparing aggregate safety documents for global regulatory submissions. · Perform report management activities. · Lead client communication. · ...
Mumbai City3 weeks ago
-
Job Title: Senior Safety Writer · Job Location: Mumbai, Maharashtra, India · Job Location Type: On-site · Job Contract Type: Full-time · Job Seniority Level: Mid-Senior level · Job Overview · Lead the preparation and review of aggregate safety, risk management, signal detection, ...
Mumbai5 hours ago
-
Lead the preparation and review of aggregate safety reports. · ...
Mumbai2 weeks ago
-
Write and review various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Development Safety Update Reports, etc. · Author and review Risk Management Plans, ad hoc reports, Benefit-Risk Evaluation reports, and medical dev ...
Mumbai Full time1 day ago
-
The job holder will lead the preparation and review of aggregate safety reports for clients globally. · ...
Mumbai1 month ago
-
Write and review various safety reports for global regulatory submissions, including but not limited to Annual Reports, Periodic Safety Update Reports, and Development Safety Update Reports. · Author and review Risk Management Plans, adhoc reports, and medical device reports. · P ...
Mumbai Full time1 day ago
-
Job Overview: · Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or i ...
Mumbai3 days ago
-
Lead the preparation and review of aggregate safety reports. Be responsible for end-to-end report management, including planning, authoring, managing review and approval steps. · Write safety reports for global regulatory submissions. · Conduct training for peers and junior team ...
Mumbai City3 weeks ago
-
Job Overview · Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or im ...
Mumbai City2 days ago
-
Lead the preparation and review of aggregate safety reports. Demonstrate ability to independently manage production of safety deliverables including complex data analyses. · ...
Mumbai City2 weeks ago
-
Lead the preparation and review of aggregate safety reports. Be responsible for end-to-end report management. · Perform allied activities like: Generation of line listings and summary tabulation. · Write and review various safety reports for global regulatory submissions. · ...
Mumbai1 month ago
-
Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Be responsible for end-to-end report management, including planning, authoring, and managing review approval submission steps per project scope requirement ...
Mumbai, Maharashtra1 month ago
-
Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Ensure timely delivery of high-quality documents to internal customers and sponsors/clients. · ...
Mumbai City1 month ago
-
Job summary · Lead the preparation and review of aggregate safety reports. Be responsible for end-to-end report management. Apply safety domain knowledge to manage deliverables of medium to high complexity. · Must have a first degree in life sciences (or equivalent) · At least 5- ...
Mumbai City1 week ago
-
This is the job summary. Lead the preparation and review of aggregate safety deliverables. Demonstrate technical expertise in medical writing teams across projects to develop high-quality scientific content. · ...
Navi Mumbai, Maharashtra1 month ago
-
The Free Press Journal is hiring an Education Desk Writer/Reporter to strengthen its digital education beat.This is a fast-paced newsroom position for journalists who thrive on timely, · accurate, · and impactful reporting. · ...
Mumbai Metropolitan Region1 month ago
Senior Safety Writer - Mumbai - Thepharmadaily LLP
Description
Qualifications:
-
Safety Writer
Full time Thepharmadaily- Mumbai
-
Safety Writer
Full time Thepharmadaily- Mumbai
-
Safety Writer
Thepharmadaily LLP- Mumbai
-
Safety Writer
Only for registered members Mumbai, Pune
-
Safety Writer
Only for registered members Mumbai City
-
Senior Safety Writer
Only for registered members Mumbai
-
Senior Safety Writer
Only for registered members Mumbai
-
Senior Safety Writer
Full time Thepharmadaily- Mumbai
-
Principal Safety Writer
Only for registered members Mumbai
-
Senior Safety Writer
Full time Thepharmadaily- Mumbai
-
Principal Safety Writer
Only for registered members Mumbai
-
Senior Safety Writer
Only for registered members Mumbai City
-
Principal Safety Writer
Only for registered members Mumbai City
-
Principal Safety Writer
Only for registered members Mumbai City
-
Senior Safety Writer and Process Lead
Only for registered members Mumbai
-
Senior Safety Writer and Process Lead
Only for registered members Mumbai, Maharashtra
-
Senior Safety Writer and Process Lead
Only for registered members Mumbai City
-
Senior Safety Writer and Process Lead
Only for registered members Mumbai City
-
Principal Safety Writer
Only for registered members Navi Mumbai, Maharashtra
-
News Writer
Only for registered members Mumbai Metropolitan Region
