Are you a meticulous writer with a passion for safety in the pharmaceutical industry? Pharmabharat.com is excited to announce a job opening for a Safety Writer based in Mumbai. This full-time position not only provides an excellent opportunity to make a meaningful impact but also allows you to collaborate with top-tier stakeholders in a dynamic environment.
About the Company
Pharmabharat.com is a leading platform dedicated to bridging the gap between the pharmaceutical industry and talented professionals across India. Our mission is to provide comprehensive information and job opportunities in the rapidly evolving pharmaceutical landscape. We are committed to ensuring that both companies and job seekers find their perfect match in the realm of healthcare and pharmaceuticals.
Job Description
As a Safety Writer, you will play a crucial role in the global regulatory submissions for various safety reports. Your primary responsibilities will include:
- Data Collection and Report Planning: Conducting data collection for planning reports and developing strategic approaches.
- Leading Meetings: Organizing and leading kick-off meetings and round table discussions aimed at resolving comments efficiently.
- Report Writing: Composing various safety reports that may include but are not limited to:
- Annual Reports (IND and others)
- Periodic Safety Update Reports (PSURs)
- Periodic Adverse Drug Experience Reports
- Development Safety Update Reports
- Risk Management Plans
- Other essential documentation
- Collaboration: Taking ownership of assigned deliverables while working closely with both internal and external stakeholders to gather necessary inputs.
- Quality Review: Performing quality reviews of safety reports prepared by junior or associate medical writers.
- Ad Hoc Contributions: Authoring or contributing to ad hoc reports, including benefit-risk evaluation reports and supporting documents for label updates.
Qualifications
Ideal candidates for this position should possess:
- A strong background in medical writing, particularly in safety report writing.
- Excellent communication and collaboration skills.
- Attention to detail and a commitment to producing high-quality work.
- Familiarity with regulatory requirements for safety reporting and submissions.