Medical Affairs- Drug Safety Director (Senior Role)
Medical Affairs- Drug Safety Director (Senior Role)
IQVIA
Job description
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 Medical Affairs- Drug Safety Director vacancy at IQVIA in Bengaluru.
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 Medical Affairs- Drug Safety Director 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 Analyses 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.
As a Medical Affairs- Drug Safety Director, you need to 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 labelling 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.
At least three years of experience in clinical practice and a further four years of experience in the pharmaceutical industry or similar field is needed for the Medical Affairs- Drug Safety Director role.
A valid medical licence or equivalent authorization in the nation or region of residence and practice is desirable.
Skills Required
Pharmacovigilance and clinical safety evaluation skills.
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 is a must for a Medical Affairs- Drug Safety Director.
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 Affairs- Drug Safety Director in India is in the range of ₹20 Lakhs to ₹25 Lakhs per year.
Career Development
This role as a Medical Affairs- Drug Safety Director, 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 Medical Affairs- Drug Safety Director role.
Click on the listing.
Fill in the relevant information and attach your updated resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
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Market insights & trends
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Hiring Trends
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