Sr Medical Manager PSS

About the Role

The role is based in India and offers the flexibility of remote work, with working hours from 2 PM to 11 PM IST. This flexibility is ideal for professionals seeking a better work-life balance while contributing to a critical aspect of the pharmaceutical industry. The position involves participation in training opportunities to advance knowledge of pharmacovigilance, ensuring that the candidate remains up-to-date with the latest developments and best practices in the field.

What You Will Do

• Conduct thorough medical reviews of serious adverse events and adverse events of special interest from clinical trials to support drug safety activities for clients.
• Prepare and medically review Aggregate Reports required by global regulatory agencies for the review of safety information for assigned products.
• Engage in signal detection and evaluation activities, and prepare and submit Ad Hoc Reports reviewing specific safety issues to global regulatory agencies for assigned products.
• Provide medical and safety expertise to project teams, communicating information regarding drug safety regulations and any changes that have occurred.
• Review laboratory values, adverse events, coding dictionaries, and data tables, listings, and figures as needed to identify drug safety issues in collaboration with the project physician.
• Assist in the preparation of pharmacovigilance materials for investigator meetings and provide pharmacovigilance support to project physicians as appropriate.
• Participate in project risk assessment activities and assume responsibility for medical and safety monitoring on assigned projects.
• Collaborate with regulatory affairs specialists to ensure compliance with global regulatory requirements.
• Develop and maintain a thorough understanding of the pharmacovigilance regulatory environment and its application to client projects.

What We Are Looking For

• MBBS and/or MD with at least 2 years of clinical medicine experience.
• Experience in the Oncology therapy area (Clinical Trial or Post-marketing PV) is mandatory.
• At least 5 years of experience working in pharmacovigilance or patient safety, either for a pharmaceutical company, health authority, or a contract research organization.
• Strong knowledge of drug safety and global regulations governing pharmacovigilance and patient safety.
• Excellent communication and team collaboration skills, with the ability to work effectively in a remote environment.
• Ability to work independently and manage multiple projects simultaneously.
• Strong analytical and problem-solving skills, with attention to detail and ability to interpret complex data.
• Familiarity with good clinical practice guidelines and regulatory requirements for pharmacovigilance.

Nice to Have

• MD who has completed an accredited residency program or equivalent and is board-eligible or certified.
• More than 5 years of experience in pharmacovigilance, with substantial knowledge of drug safety regulations and practices.
• Experience with pharmacovigilance software and databases.
• Certification in pharmacovigilance or a related field.

Benefits and Perks

• Competitive salary and benefits package.
• Opportunity to work remotely with a flexible schedule.
• Professional development and training opportunities in pharmacovigilance.
• Collaboration with a global team of professionals in the pharmaceutical industry.
• Access to the latest tools and technologies in pharmacovigilance.
• Recognition and reward for outstanding performance and contributions to the team.
• Comprehensive health insurance and other benefits to support work-life balance.

• Highlight relevant experience: Ensure your resume and cover letter emphasize your experience in pharmacovigilance, especially in the Oncology therapy area.
• Develop a strong understanding of regulatory requirements: Familiarize yourself with global regulations governing pharmacovigilance and patient safety to stand out as a candidate.
• Improve your analytical skills: Practice interpreting complex data and developing reports to demonstrate your ability to work with pharmacovigilance data.
• Prepare for remote work: Showcase your ability to work independently and collaboratively in a remote environment, highlighting tools and strategies you use to stay productive.
• Stay updated on industry developments: Follow industry news and attend webinars or workshops to stay current on the latest pharmacovigilance practices and regulatory updates.
• Tailor your application: Customize your application materials for the Sr Medical Manager PSS role, emphasizing how your skills and experience align with the job requirements.
• Be ready to discuss your experience with pharmacovigilance software: Prepare examples of how you have used pharmacovigilance software and databases in your previous roles.