PV Scientist - Medical Assessment (Medical Writing)

The PV Scientist is primarily responsible for the conduct of benefit-risk assessment activities including: ad hoc data analysis in support of internal/external queries; preparation review and submission of aggregate reports; signal detection; support of benefit-risk evaluation efforts; generation of risk management plans (RMPs) risk evaluation and mitigation strategies (REMS) identification and tracking of risk minimization 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. Other activities relevant to the medical assessment responsibilities can also include: Query management; coordination with internal and external stakeholders for assigned medical assessment activities and quality review of deliverables.

All of the above are conducted in accordance with regulatory requirements and internal DRL standards.

Main Responsibilities:

• Signal management:
  • Conduct signal management activities for assigned products performing initial review of signal alerts ensuring signal detection is conducted in a regular timely manner in accordance with schedule. This may include interaction with the LifeSphere Signal Management System and/or review of outputs generated from the system.

• Aggregate Reports and RMPs:
  • Contribute to the scheduling of aggregate reports RMPs and other safety related documents to ensure all required reports are documented on the report calendar. Maintain and harmonize global trackers for all aggregate reports across the regions
  • Preparation of aggregate reports including: PSUR PBRER PADER Annual Reports DSURs ACOs. Conduct peer quality review of aggregate reports and quality review of reports generated by the vendor and by internal resources. Ensure all aggregate reports are prepared reviewed and submitted in line with regulatory requirements
  • Prepare RMPs and contribute to REMS activities as required
  • Contribute to the implementation and tracking of additional risk minimization measures in collaboration with PV physicians local affiliates and third party partners
• Prepare Health Hazard Evaluations and other ad hoc safety reports as requested
• Conduct benefit-risk evaluations under the supervision of PV physicians
• Clinical & Regulatory Activities: Provide safety input to other cross-functional documents including clinical study protocols study CRF statistical analysis plan (SAP) coding review reconciliation 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: under the supervision of PV physicians 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
• Provide data for internal compliance meetings monthly report and for inclusion in the PSMF as required
• Raise deviations to PV processes where identified
• 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
• Initiate or support the development and revision of PV Medical Assessment SOPs and work instructions. Also participate in the review of cross-functional SOPs which include reference to PV Medical Assessment Activities.
• Support PV training for new members of PV team and non-PV personnel particularly product-specific scientific and medical training

Perform other ad hoc PV related activities as requested by head medical assessment

Relationship Management

• Working within PV team and cross-functionally
• Interactions with vendors/service providers for PV activities

Process Improvement / Standardization

• Participate in process improvement initiatives as applicable
• Participate in safety database/PV system upgrade activities such as defining user requirements and conducting user acceptance testing

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
• Excellent time management and organizational skills
• Good knowledge of computer applications and software including MS Word Excel PowerPoint etc.

Qualifications :

M. Pharm (Pharmacology) or equivalent with 3 to 7 years of experience in pharmacovigilance with experience in writing and reviewing PV Medical Writing

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 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 1150 drug master files across key therapy areas such as Oncology Cardio-vascular Central Nervous System and Anti-Diabetes. The 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 :

Full-time