Mgr Pharmacovigilance

Teva Pharmaceuticals; Karnataka; On-site; INR 1,800,000 - 3,000,000; Full time

Benefits offered by this job

Generous annual leave

Flexible working schedules

Health support

Job summary

Teva, a leading biopharmaceutical company, seeks a Medical Safety Reviewer to perform trial-related AE/ADR reviews and provide pharmacovigilance expertise. The role requires MBBS with internship, 1–2 years clinical, 3–4 years PV experience, and fluency in English.

You will work with global teams in PV case processing and labeling discussions. Based in Karnataka, India, this full-time position offers opportunities to influence safety operations, participate in audits, develop SOPs, and contribute

Qualifications

• MBBS degree with internship and valid medical license.
• Clinical medical experience 1–2 years and PV experience 3–4 years as medical safety reviewer.
• Board approved/certified equivalent or 2 years post-graduation.
• Fluent in English.
• Project management experience is an advantage.

Responsibilities

• Perform medical review and clarification of trial-related AEs & ADRs including narrative content, queries, coding for events and lab reports, expectedness, seriousness, causality, labelling and medical assessment comments as applicable.
• Serve as a global safety physician and internal/external PV consultant to case processing groups, providing inputs on labeling, causality and MedDRA coding.
• Maintain awareness of medical-safety-regulatory developments and participate in trainings, audits, product transitions, and knowledge transfer initiatives.
• Support audits and inspections for case processing & medical review aspects.
• Create and update Standard Operating Procedures and Working Instructions for ICSR management.
• Maintain regular communication with external vendor regarding medical review workflow and oversight.
• Perform routine quality checks to measure medical review quality for vendor and in-house teams.
• Attend internal meetings with stakeholders and vendors on medical assessment queries.
• Provide support to EU Qualified Persons for Pharmacovigilance (QPPV) teams as applicable.
• Signal detections and participate in PSUR/DSUR surveillance activities and Business Continuity Plans.

Skills

Medical safety

Pharmacovigilance

English fluency

Cross-functional comms

Time management

Proactivity

Analytical thinking

Project management

Education

MBBS / Medical degree

Job description

We Are TevaWe’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.Our Team, Your ImpactThis section is where we attract the attention of potential candidates and sell the role. How has the role come about? What makes it appealing? What are the key responsibilities? How is the role better with Teva than with another company? Wherever possible, we should bring through the essence of our EVP pillars, i.e., we care, we’re in it together, and we make work fulfilling.How You’ll Spend Your DayPerform medical review and clarification of Trial related (AE's) & Post marketing Adverse Events (ADR's) including narrative content, queries, coding for events and lab reports, expectedness, seriousness, causality, labelling and medical assessment comments as applicable.Serve as a global safety physician and as an internal (within Teva) & external (to vendors) consultant to pharmacovigilance case processing groups. To have active interactions and provide inputs with other functions for topics related to labelling, causality, seriousness, MedDRA coding and other medical concepts etc.Maintain awareness of medical-safety-regulatory industry developments to participate in trainings, workshops, product transitions, audit preparations, supporting UAT activities and knowledge transfer transition initiatives.Support audits and inspections for case processing & medical review aspectsCreate and update Standard Operating Procedures and Working Instructions to ensure optimal operational management of ICSR and related activitiesMaintain regular communication with the external vendor regarding medical review workflow, process updates and maintain a necessary oversight to address any gaps/risks.Perform routine quality check to measure the medical review quality for vendor and in-house teamAttend and conduct internal meetings with various stake holders and vendors on various queries/ clarification related to medical assessment concepts for better awareness amongst case processing groups.Provide support to EU Qualified Persons for Pharmacovigilance (QPPV) teams as applicable. Signal detections following preparation of Risk Management Programs, PSUR/DSUR surveillance activities, participate in Business Continuity Plans (BCP) as required.Manage paid time off, appropriate backups for the team to ensure smooth operations with minimal disruption.Your Skills and ExperienceMedical Degree (MBBS with 5.5 years degree which includes internship of 1 year). Board approved/certified equivalent or 2 years post-graduation with valid medical license.Clinical medical experience of about 1-2 years and PV experience of about 3-4 years as medical safety reviewer is recommended so as to fulfil the job role technical requirements on medical judgements.Project Management experience is an advantage.Fluent in English.Also Good to HaveAdaptability & Flexibility: The ability to respond positively to change and new ways of working; be prepared to rise to the challenge of dealing with the unfamiliar and cope with the new or unexpected. Effectively address work-related problems, pressures and stresses in a professional and positive way. Ability to adapt, adjust and change to new situations and shift strategies to meet different types of challenges. Can effectively cope with change; can decide and act without having the total picture; can comfortably handle risk and uncertainty.Cross-functional Communication The ability to communicate ideas, strategies and concerns to cross-functional stakeholders; Understanding of appropriate audience for discussions, and ability to identify appropriate stakeholder for specified messages; Ability to facilitate meetings and drive discussion around a specified agenda; Ability to articulate a business case.Time-management (Prioritization): Ability to handle multiple tasks/projects simultaneously. Determination to stay focused on results and deadlines until the task or project is completed; Spends his/her time and the time of others on what’s important.Proactivity: To challenge and lead the organization and self to achieve results and excellence. Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.Critical & Analytical Thinking: Having a process of breaking down complex information into components to analyze, interpret, evaluate and construct reasoned arguments in order to solve a problem or reach a conclusion. Breaks down raw information and undefined problems into specific, workable components that in-turn clearly identifies the issues at hand. Makes logical conclusions, anticipates obstacles, and considers different approaches to the decision-making process.Results and Performance-Driven: Assumes personal ownership and accountability for business results and solutions; consistently delivers results that meet or exceed expectations; makes the customer central to all thinking; keeps the focus on driving customer value.Excellent Communication Skills, both written and Oral: Communication style should be diplomatic and direct, but not confrontational. He or she must be able to summarize information in an articulate, clear, tangible, manner both in written form and orally.Salary RangeHow We’ll Take Care of YouAt Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.Already Working @Teva?Make sure to apply through our internal career site on Twist—your one-stop shop for career developmentTeva’s Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.