PV Physician-Medical Assessment

Purpose:

PV Physician is primarily responsible for the oversight of and provision of medical input to benefitrisk 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 benefitrisk 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 benefitrisk 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 thirdparty partners.
• Clinical & Regulatory Activities: Provide medical/safety input to other crossfunctional 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 PVrelated 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 crossfunctional SOPs which include reference to PV activities.
• Support PV training for new members of PV team and nonPV personnel particularly productspecific 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 crossfunctionally 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.

Qualifications :

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 decisionmaking skills.

Additional Information :

About the department

Global Manufacturing Organisation (GMO)
At Dr. Reddys 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 stateoftheart 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 1150 drug master files across key therapy areas such as Oncology Cardiovascular Central Nervous System and AntiDiabetes. 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. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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 !/ 

Remote Work :

No

Employment Type :

Fulltime