Pharmacovigilance Medical Writer II – Join Our Global Team in Pune
Summary:
PrimeVigilance, a leading global provider of pharmacovigilance (PV) and regulatory services, is seeking a talented and motivated Pharmacovigilance Medical Writer II to join our expanding team in Pune, India. This is an exceptional opportunity for a skilled medical writer with strong experience in PV to contribute to drug safety and regulatory compliance within a supportive and dynamic global environment. If you have a passion for scientific writing, a keen eye for detail, and a commitment to excellence, we encourage you to apply.
About PrimeVigilance:
PrimeVigilance is dedicated to ensuring the safety of medicines and improving patient outcomes worldwide. We offer a comprehensive range of pharmacovigilance and regulatory services to pharmaceutical companies, biotechnology firms, and healthcare organizations. Our commitment to quality, integrity, and innovation makes us a trusted partner in the industry.
Job Description:
As a Pharmacovigilance Medical Writer II, you will play a critical role in the creation and maintenance of essential safety documentation. You will be responsible for producing high-quality aggregate safety reports, contributing to risk management strategies, and ensuring compliance with global regulatory requirements. This position offers the opportunity to work on a variety of projects, collaborate with experienced professionals, and advance your career within a growing organization.
Key Responsibilities:
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Aggregate Safety Report Writing: Prepare comprehensive and accurate PV aggregate reports, including:
- Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Periodic Adverse Drug Experience Reports (PADERs)
- Development Safety Update Reports (DSURs)
- Risk Management Plans (RMPs)
- Annual Company Reports (ACOs)
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Quality Control Review: Conduct thorough QC reviews of safety deliverables to ensure accuracy, consistency, and compliance with regulatory guidelines.
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Project Support: Assist Project Managers in report scheduling, planning, and tracking to ensure timely delivery of projects.
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Process Improvement: Collaborate with Quality and Training teams to enhance Standard Operating Procedures (SOPs), templates, and training materials, contributing to continuous improvement within the department.
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Documentation Management: Ensure the quality and integrity of all documentation, adhering to established procedures and regulatory requirements.
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Client Interaction: Attend client kick-off meetings, audits, and inspections as required, representing PrimeVigilance with professionalism and expertise.
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Mentoring and Training: Provide guidance and mentorship to Associate Medical Writers, supporting their professional development and growth within the company.
Qualifications:
We are seeking a highly motivated and skilled individual with the following qualifications:
- Educational Background: MD / Pharmacy / Life Science degree (Master’s/PhD preferred).
- Pharmacovigilance Experience: Strong hands-on experience in Pharmacovigilance, including case processing, signal detection, and risk management.
- CRO Experience: Experience working in a Contract Research Organization (CRO) environment is highly desirable.
- Communication Skills: Excellent English communication skills, both written and verbal, with the ability to convey complex scientific information clearly and concisely.
- Scientific Writing Skills: Proven ability to produce high-quality scientific writing, including aggregate safety reports and other regulatory documents.
- Organizational Skills: Ability to prioritize multiple tasks, manage deadlines effectively, and deliver accurate results under pressure.
- Mentoring Experience: Experience in mentoring or training junior team members is a significant advantage.
- Teamwork: A team-oriented mindset with strong interpersonal skills and the ability to collaborate effectively with colleagues from diverse backgrounds.
- Attention to Detail: Meticulous attention to detail and a commitment to accuracy in all aspects of work.
Why Join PrimeVigilance?
At PrimeVigilance, we are committed to creating a supportive and rewarding work environment where our employees can thrive. We offer:
- Global Exposure: Opportunities to work on projects spanning Europe, North America, and Asia, gaining valuable international experience.
- Career Development: Extensive training programs and internal career development opportunities to help you reach your full potential.
- Collaborative Culture: A friendly and collaborative international team where you will be valued and supported.
- Work-Life Balance: A strong focus on work-life balance and mental well-being to ensure your overall health and happiness.
- Company Values: We are guided by core values of Quality, Integrity, Trust, Agility, Belonging, and Collaboration, which shape our culture and drive our success.
Benefits:
We offer a competitive salary and benefits package, commensurate with experience.
How to Apply:
If you are a qualified and motivated individual seeking a challenging and rewarding career in pharmacovigilance, we encourage you to apply. Please submit your resume and cover letter detailing your relevant experience and qualifications.
We look forward to hearing from you!
