Zydus Lifesciences hiring Assistant Manager – Medical Writing (Pharmacovigilance)
Zydus Lifesciences hiring Assistant Manager – Medical Writing (Pharmacovigilance)
Corporate Office|Corp. Office, Ahmedabad, Gujarat, India
Zydus Lifesciences, a leading pharmaceutical company, is currently hiring for the position of Assistant Manager – Medical Writing (Pharmacovigilance). This role presents an excellent opportunity for individuals who are passionate about pharmacovigilance and medical writing and have a desire to work with a dynamic and innovative organization. As an Assistant Manager in Medical Writing, you will be responsible for preparing high-quality medical documents, including clinical study reports, protocols, investigator brochures, and regulatory documents. You will work closely with cross-functional teams, including clinical operations, regulatory affairs, and biostatistics, to ensure that all documents are produced accurately and on time. If you have a strong background in medical writing and pharmacovigilance, excellent communication and organizational skills, and a desire to work in a fast-paced and challenging environment, then this could be the perfect opportunity for you to take the next step in your career
Division; PHARMACOVIGILANCE
Job posted on; Mar 10, 2023
Employee Type; C-C8-Confirmed-HO Executive
Experience range (Years); 4 years – 8 years
Job description (major activities):
- Prepare and maintain periodic reports schedule.
- Generate line listing/safety data for preparation of Periodic Safety Update Reports (PSURs)/Periodic Adverse Drug Experience Reports (PADERs)/Risk Management Plans (RMP)/other periodic reports, as required.
- Preparation, review, and submission of Periodic Safety Update Reports (PSURs)/Periodic Adverse Drug Experience Reports (PADERs)/Risk Management Plans (RMP)/other periodic report.
- Perform signal management activities.
- Ensure compliance (quality, procedures, regulations, timeliness, consistency) related to periodic reports.
- Impart training on medical writing activities, as and when required.
- Perform other ad hoc/pharmacovigilance activities as assigned by HoD-GPV.
