Glenmark Pharmaceuticals is a globally recognized pharmaceutical company with a robust presence in over 80 countries. Known for its commitment to innovation and excellence, Glenmark specializes in research-driven solutions, spanning diverse therapeutic areas. The organization fosters an inclusive environment that encourages professional growth and values impactful contributions.
Responsibilities in the Job
As an Aggregate Report Writer, your primary responsibilities will include:
- Composing and managing aggregate safety reports such as PSUR (Periodic Safety Update Reports), PBRER (Periodic Benefit-Risk Evaluation Reports), and DSUR (Development Safety Update Reports).
- Ensuring adherence to regulatory guidelines and company protocols while drafting safety reports.
- Collaborating with cross-functional teams to gather and analyze medical information for accurate reporting.
- Maintaining precision and attention to detail when handling complex medical data.
- Keeping updated with the latest industry standards and pharmacovigilance practices to ensure compliance.
Qualifications
To excel in this role, you should possess the following qualifications:
- A degree in Pharmacy, Medicine, Life Sciences, or related fields.
- Prior experience (1–5 years) in medical writing or pharmacovigilance, with expertise in creating aggregate reports like PSUR, PBRER, and DSUR.
- A strong understanding of regulatory requirements in pharmacovigilance.
Skills Required
- Medical Communication Proficiency: Ability to interpret and articulate complex medical information effectively.
- Attention to Detail: Meticulous approach to ensure accuracy in safety reports.
- Communication Skills: Excellent written and verbal skills for seamless collaboration and clear documentation.
- Regulatory Knowledge: Familiarity with global pharmacovigilance standards and practices.
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