Drug Safety Physician (Senior Role)

Looking for a role where you get to provide medical support to pharmacovigilance activities, and support to assessment of potential drug-related risks? Check out this drug safety physician vacancy at IQVIA.

 Company Description 

IQVIA is a leading global provider of advanced analytics, technological solutions and contract research services to the life sciences industry. The company collaborates with organizations across the life sciences sector to support the development and commercialization of medical treatments. It works at the intersection of data and knowledge to improve healthcare decision-making and patient outcomes.

 Job Summary 

The PV Physician is a full time, hybrid role located in Bengaluru, India. The position will involve pharmacovigilance and medical oversight of clinical trials and other drug safety programs. Responsibilities include analyzing adverse event data, evaluating product safety data, assisting with regulatory documentation, and providing medical advice to project teams. Main responsibilities include the coordination of worldwide safety assignments, support of client talks and mentorship of junior medical safety professionals.

 Key Responsibilities 

• Medical review of adverse events (AEs) documented in clinical trials and adverse drug reactions (ADRs) detected after a medication is marketed. Review case narratives, medical questions, coding, seriousness, expectedness and causality assessments.

• Prepare, amend and medically review Analyzes of Similar Events (AOSE) for accelerated safety cases in compliance with applicable regulatory criteria.

• Provide expert advice to pharmacovigilance case processing teams on medical safety issues relating to assigned projects.

• Review cumulative safety data and clinical data to keep up to date on a product's safety profile.

• Review of medical coding of adverse events, medical histories, concurrent medications, and other clinical data to ensure accurate interpretation.

• Present medical safety review and clinical data evaluation outcomes at client meetings.

• Review and update regulatory safety documentation including yearly Investigational New Drug reports, monthly safety reports, and benefit-risk evaluation reports.

• Provide medical knowledge to help build and update development risk management plans, EU risk management plans and US risk evaluation and mitigation techniques.

• Provide medical expertise for product labeling operations, including assessment and updating of safety-related information.

• Attend Data Safety Monitoring Board meetings and safety evaluations by Safety Monitoring Committees.

• Support the creation of the integrated safety summary and the relevant portions of the common technical document.

• Review safety reports of drugs and other documentation used to evaluate the advantages and dangers of a pharmaceutical product.

• Review and approve Project Safety Plans and Medical Monitoring Plans as part of the scope of project obligations as agreed.

• Review clinical study protocols, Investigator’s Brochures and Case Report Forms, to ensure that important safety information is addressed and collected effectively.

• Led medical safety projects with different advisers, organizing project-specific training, communications, delivery and quality checks.

• Participate in project discussions, internal medical safety meetings and client meetings as appropriate.

• Ensure that medical safety deliverables are delivered according to approved contractual and regulatory timelines.

• Provide medical escalation support for medical information assignments and initiatives involving EU Qualified Persons for Pharmacovigilance.

• Help with proposal reviews, service assessments and budgeting for medical safety initiatives Contribute to client presentations to explain and sell the services

 Educational Qualification 

• An internationally recognized medical degree from an accredited university.

• At least three years of experience in clinical practice and a further four years of experience in the pharmaceutical industry or similar field.

• Equivalent combination of education, training and experience will be considered.

• A valid medical licence or equivalent authorization in the nation or region of residence and practice is desirable.

 Skills Required 

• Medical knowledge: Pharmacovigilance and clinical safety evaluation.

• Knowledge of clinical trials, pharmaceutical research and drug development procedure.

• Knowledge of clinical research legislation and safety guidelines and GCPs.

• Ability to assess adverse events, adverse drug reactions, cause, seriousness and expectedness.

• Experience in review of medical safety data and regulatory documents.

• Strong analytical judgment and ability to assess clinical and safety data.

• Excellent communication skills with clients, colleagues and cross-functional teams.

• Ability to advise on a variety of assignments and to adjust to evolving project requirements.

• Good planning and organizational skills including prioritizing and meeting deadlines.

• Ability to develop and maintain effective working relationships with colleagues, managers and clients.

• Leadership skills for organizing worldwide initiatives, upholding quality standards and assisting junior team members.

• An understanding of changing medical safety and regulatory standards.

 Salary Structure 

The projected total average compensation of a Medical Safety Director in India is ₹20 Lakhs to ₹25 Lakhs per year.

 Career Development 

This role as a drug safety physician, provides opportunity to gain experience in pharmacovigilance, clinical safety and regulatory reporting. Opportunities to lead global initiatives, advise customers and mentor medical safety specialists may also serve to enhance leadership skills, and can be used to move into broader medical safety and drug development leadership roles.

 How to Apply 

• Go to our job portal and search for Drug Safety Physician role.

• Click on the listing for the full job description and eligibility requirements.

• Fill in the relevant information and attach your updated resume.

• Submit your application.