PV Physician-Medical Assessment

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Purpose:

PV Physician is primarily responsible for the oversight of and provision of medical input to benefit-risk assessment activities including: ad hoc data analysis in support of internal/external queries; preparation and review of aggregate reports; signal detection and evaluation; support of benefit-risk evaluation efforts; generation and/or review of risk management plans (RMPs), risk evaluation and mitigation strategies (REMS), identification of risk minimisation measures; handling of responses to Regulatory Authority queries, scientific/medical input to other safety related documentation including Health Hazard Evaluations, clinical study protocols, final study reports, dossier documents, Medical Affairs activities, commercial/marketing information, as needed and providing support for product labelling activities.

Main Responsibilities:

• Medical Review quality control of medical assessment of individual case safety reports (including coding, seriousness, expectedness, and company causality assessments) done by the vendor.
• Contribute to the scheduling of aggregate reports, RMPs and other safety related documents to ensure all required reports are documented on the report calendar.
• Provide medical input and/or review of Medical Assessment deliverables including but not limited to aggregate reports including: PSUR, PBRER, PADER, Annual Reports, DSURs and ACOs.
• Conduct peer quality review of aggregate reports, and quality review of reports generated by the vendor.
• Support the PV Scientists in ensuring all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements.
• Provide medical input to signal management activities for assigned products, ensuring signal detection is conducted in a regular, timely manner in accordance with schedule. 
• Signal evaluation: Validation of potential signals and ensure appropriate actions are taken for confirmed signals. 
• Summarize findings and present to the Head of Medical Assessment, Regional PV Heads and Glboal Head of Global Pharmacovigilance at appropriate forums such as signal management committee.
• Conduct aggregate safety data review on an ad hoc basis to support benefit-risk evaluations.
• Provide medical input to RMPs/REMS and aRMMs  as required and review RMPs authored by PV Scientists.
• Prepare and/or review Health Hazard Evaluations and other ad hoc safety reports as requested.
• Contribute to the identification and design of additional risk minimization measures and support their implementation in collaboration with PV Scientists, local affiliates and third-party partners.
• Clinical & Regulatory Activities: Provide medical/safety input to other cross-functional documents, including clinical study protocols, study CRF, statistical analysis plan (SAP), coding review, final study reports, dossier documents and other documents required to support filing activities.  Participation in product/project team meetings.
• Provide safety input, advice and support to commercial, marketing and Medical Affairs activities as required.
• Labeling document review: provide medical input to reference safety information, Investigator Brochures, product labels and patient information leaflets to ensure the most up to date and accurate safety information is present in all labeling information.
• Regulatory Authority query management: liaise with Regulatory Affairs to respond to PV-related Regulatory Authority queries; coordinate with various stakeholders when finalizing the response, ensure responses are tracked to closure.
• Participate in due diligence activities for product acquisitions/divestments as required.
• Participate in development of CAPA and take ownership of CAPA completion where assigned.
• Participate in regular, scheduled meetings with PV team/service provider/third parties as required.
• Support for PV QMS: Support the development and revision of department SOPs and work instructions. And participate in the review of cross-functional SOPs which include reference to PV activities.
• Support PV training for new members of PV team and non-PV personnel, particularly product-specific, scientific and medical training.
• Act as SME for above activities during audit and regulatory authority inspections, as needed.
• Any other activity assigned by Head Medical Assessment.

Relationship Management

• Working within PV team and cross-functionally with key stakeholder functions including Clinical, Regulatory Affairs, Medical Affairs, Commercial Teams and Business Units.
• Interactions with vendors/service providers for PV activities.

Process Improvement / Standardization

• Participate in process improvement initiatives under supervision of Head of Medical Assessment and Global Head of Pharmacovigilance to promote internal audit and regulatory inspection readiness.
• Participate in safety database/PV system upgrade activities such as defining user requirements and conducting user acceptance testing.

Education: MBBS preferably with MD

At least 5 years of relevant PV experience after MBBS

Desired Skills & Competencies

• Good working knowledge of PV regulations including FDA, EU & local requirements.
• Strong data analysis and report writing skills.
• Excellent teamwork and interpersonal skills.
• Strong problem solving and decision-making skills.

About the department

Global Manufacturing Organisation (GMO)
At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry.
We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future.

Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/