Pharmacovigilance and Clinical Research (SERM) job opportunity for an MD candidate who is a PV Physician with ICSR and extensive Aggregate report (DSUR, PSUR, PBRER) experience along with signal detection and RMP exposure/working knowledge. You must hold proficiency in Pharmacovigilance, case processing, drug safety, signal detection, clinical trials, and clinical safety. You must have strong understanding of bio statistical and bioequivalence studies. You must have expertise in aggregate medical reports reviewing.

If you are post graduate in MD and have the relevant experience, go ahead and apply!!

Location: Mumbai (Thane)

Your Employer: A leading, global firm providing creative and strategic analytics, IT and consulting solutions for the entire enterprise value chain.

Responsibilities :

- Conducting safety checks of the products in clinical development by proper evaluation and risk management.

- Performing the aggregate reviewing of the medical reports (DSUR, PSUR, PBRER in order to check the adverse event so as to meet the global compliances and requirements.

- Performing clinical trials and cross-functional clinical safety in order to ensure the safety objectives and risk minimization.

- Carrying out the daily signal detection process for the products in relation with the various signal management tools and along with the product scientists and the tools for case awareness.

- Providing recommendations for complex issues and provide regulatory supporting documentation to label the updates.

- Overviewing reports and documents and authoring the periodic regulatory documents to the global regulatory submission for the new products.

- Participating in the process improvement.

Requirements :

- Post-graduate in MD with relevant experience of minimum 10 years in pharmacovigilance, clinical trials, clinical research, drug safety, drug development, signal detection etc.

- Strong knowledge of pharmacovigilance with proficiency in aggregate report reviewing.

- Expertise in Signal detection and Risk Management activities.

- Experience of working with Global R&D and Global Medicinal Product Development teams.

- Strong hold in clinical research i.e. mainly into Clinical Trials, Bioequivalence Studies, Bio statistical Studies, Observational Studies etc.

- Good knowledge of the drug and medical terminology and the drug development process.

- Ability to manage work pressure with strong problem solving skills and handling complex situations.

What's in the store for you?

- Opportunity to work with fast paced organization.

- Fast track career growth.

Reach us

If you think this role will add value to your career, kindly write me an email along with your updated CV  for a confidential discussion on the role.

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