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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

Title: PV Scientist - Senior Expert

Location: Bangalore

Purpose of the Role:

We are seeking a highly motivated and skilled Pharmacovigilance Scientist to collaborate with global safety leads and program safety leads. This role is essential for providing integrated medical safety strategies for assigned investigational and core (high-risk) marketed products, including input into safety aspects of clinical development, risk management, and benefit-risk management.

Your role

Signal Detection and Management:

Perform safety monitoring using dedicated tools (e.g., Spotfire, EVDAS, Empirica Signals) for signal detection.

Review and analyze clinical and safety database outputs; interpret aggregate safety data from clinical trials and post-marketing sources.

Review scientific literature for safety surveillance and signal detection.

Support the analyses of safety signals, contribute to authoring signal evaluation reports, and participate in relevant safety governance meetings.

Support communication of findings from Emerging Safety Issue Reports to external stakeholders.

RMP Updates and Periodic Safety Reports:

Retrieve/summarize data from various sources in support of authoring and providing content for Risk Management Plans (RMPs) and periodic safety reports.

Support local adaptation of RMPs and respond to health authority questions.

Submissions and Safety Variations:

Contribute to delivery of safety relevant documents of the Common Technical Document (CTD).

Contribute to ISS/SCS IAP, health authority briefing documents, and product information and clinical overview addendum.

Clinical Trial Activities:

Provide input into safety sections of the Investigational Medicinal Product Dossier (IMPD), Investigator's Brochure (IB), and Informed Consent Form (ICF).

Support delivery of safety-related input for clinical trial documents, including protocols and reports.

Provide safety related input for data monitoring committees with safety-related documentation.

Other Activities:

Respond to queries from auditors/inspectors and participate in interviews.

Contribute to the design and implementation of post-authorization safety studies.

Develop and maintain MedDRA CMQs for signal analysis and aggregate safety data.

Create product-specific training for internal and external stakeholders.

Provide expert input into process standardization and improvement within GPS and GD.

Who you are:

Experience Required:

MD, or PhD/advanced science degree or tertiary level qualifications in a biomedical/health related field. Fluent in written and spoken English.

Qualification:

Over 4 years of Pharmaceutical industry experience or similar (e.g. Health Authority).

Experience in Pharmacovigilance risk management in both clinical development and post-marketing areas, including submission experience.

Ability to work collaboratively in a global team environment

Tech savy with strong analytical and communication skills

We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, colour, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!