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Opella

Study Safety Reporting Manager

Hyderabad, Pakistan

Job title: Study Safety Reporting Manager

Location: Hyderabad

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.

Our mission: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide.

At the core of this mission is our 100+ loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and four specialized science and innovation development centers.

Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.

B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet.

Find out more about our mission to bring health in your hands at

www.opella.com.

About the job:

Reporting to the Global Safety Operational Group Lead at the Science (COE) at Hyderabad and will be working closely with the other global stakeholders including Case Management Head & PV Ops Head for other relevant regulatory reports from clinical trials and post-marketed studies.

Main responsibilities:

This role is responsible to ensure patient safety data from clinical trials and post-marketed studies is accurately represented in regulatory reports.

Build and maintain strong partnerships with cross-functional teams including Clinical Trial Leads, RWE Study Leads, Regulatory Affairs, Medical Affairs, and vendor organizations to support DSUR/SASR/PBRER/ACO requirements.

Collaborate closely with PV Ops Head, Global Safety Officer, Periodic Report Authoring Team, and other global functions to support safety reporting and regulatory documentation.

Validate study lists and generate high-quality cumulative clinical exposure data from CTMS and non-interventional studies for periodic safety reports.

Maintain compliance with global PV regulations and define standards for safety reporting based on evolving Health Authority expectations.

Ensure all relevant safety sections of the clinical study protocols, SAE forms, and eCRFs are aligned with Opella SOPs and global regulatory requirements.

Access and manage ongoing study data from CRO repositories and CTMS, ensuring accurate safety data transfer and configuration in PV databases.

Provide strategic guidance to transversal teams for complex safety data analysis and regulatory responses, including ad hoc Health Authority queries.

Drive continuous process improvements to enhance compliance, quality, and operational efficiency.
Support case medical evaluator participation in safety analysis, enabling early identification and management of potential safety issues.
Support PV Ops function in the oversight of local, regional, corporate, and vendor safety reporting activities.

Actively contribute to global PV initiatives and collaborate with the Global Safety Officer on clinical and post-marketing program documentation.

Latitude of Action:

Validate list of studies for periodic reports versus previous issue to ensure consistency before making them available to stakeholders on a SharePoint.

Ensure complete safety datasets from all Consumer Healthcare studies (interventional/non-interventional) in agreed formats for ready inclusion into periodic safety reports or any other regulatory reports.

Inform relevant stakeholders of planning of periodic safety reports and addendum to clinical overview for the products they are responsible for.

Produce predefined list of studies required for the preparation of periodic safety and regulatory reports according to master planning table, or for ad hoc audits and inspections.

Validate the list of studies for periodic reports versus previous periodic safety report to ensure consistency before making them available to stakeholders on a SharePoint.

Determine whether new studies were started or completed since the previous periodic report.

Maintain and ensure cumulative exposure based on either receipt of information from the contact person or after receipt of clinical study report information.

Contribute to defined data remediation process for “old” products.

For non-global studies contact, inquire about access to datasets or aggregated data: Depending on cumulative exposure accountability, transfer local study exposure information to Statistician and/or store the data to further prepare cumulative clinical exposure tables for products without global project team according to rules established in the data remediation plan This requires consolidating prospectively the historical list of studies in scope according to this plan that depends on the age of the product, the type of access to data, etc.

Follow up on the receipt and verify the completeness of data of ongoing or completed studies during the reference period received from affiliates for local studies or other contact for studies not managed by the Opella clinical department.

Track the assessment of the report in the “disclaimer” document tracker and/or remediation meeting minutes.

Ensure new studies are configured into the Opella’s PV Safety database.

Provide support in maintaining the planning of the DSUR with the coordination of the clinical study teams, global regulatory teams, and countries.

Role Impact:

Responsible to maintain compliance with all applicable PV regulations from safety data reporting from clinical studies

Define, establish, and maintain global standards and expectations for Safety reporting based on expertise and awareness of Health Authority regulations on a global basis.

Responsible to access ongoing study data from CRO repositories and Opella CTMS and ensure safety data transfer in PV database at the end of the study.

This individual must provide direction and guidance to transversal teams in developing the complex analysis of clinical study and post-marketing data as well as in responding to Health Authorities.

Responsible for implementing and maintaining the PSR-related tools and systems.

Provide study-related information from Clinical Operations and Real-World Evidence for PV System Master File.

Bring expertise for upgrade or development of new tools linked to CTMS or processes which identifies and monitors data quality and consistency.

Support quality improvement projects through optimized processes, new technologies and innovation.

Scope:

The Study Safety Reporting Manager is responsible for ensuring accurate representation of patient safety data from clinical trials and post-marketed studies in regulatory reports.

This role involves extensive cross-functional collaboration with internal and external stakeholders to manage study configurations, validate cumulative exposure data, and maintain compliance with global PV regulations.

The individual also drives process improvements, oversees safety data integration from various sources, and provides strategic guidance for regulatory responses and safety surveillance activities.

About you:

Qualifications:

Solid understanding of medical concepts and familiarity with safety activities in drug development and post-marketing and global safety health authority requirements.
Experience working with global safety databases, including case management, periodic reports and comprehensive clinical data analysis.
Author and/or process owner of controlled procedural documents (i.e., SOPs, Master Templates, Technical Documents, etc.).
Solid knowledge of GCP, ICH and Global regulations.
Inspection and audit support, including readiness activities
Strong project management experience; ideally including having led outsourcing initiatives.
Extensive experience leading compliance and quality management activities.
Extensive knowledge and experience in leading transversal teams in formulating and writing Health Authority Responses.
Demonstrated success in partnering and influencing across a matrix environment with exceptional executive communication skills.
In depth understanding of data and the application of a variety of analytical techniques to derive insights from a set of objective and subjective data inputs.
Pharmaceutical industry experience, especially in pharmacovigilance safety reports area
Capability to organize and multitask activities, effectively prioritize and allocate resources
Computer literacy especially in Windows based programs
Ability to solve problems, to take initiative, to meet challenges, negotiation skills
Fluent spoken and written English.
Excellent written and oral communication skills
Ability to effectively work with others throughout the organization, primarily affiliates/Country PV organization
Fluent spoken and written English.

Preferred Qualifications:

Master’s degree in pharmacy/Life sciences or HCPs with a minimum of 8-10 years of pharmacovigilance safety reporting handling of ICSRs & Periodic Reports from both clinical trials and post-marketed studies.
Any additional experience in consumer healthcare portfolio and cosmetic products would be an added advantage.

Why us?

At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.

We Are Challengers.

We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:

All In Together: We keep each other honest and have each other's backs.

Courageous: We break boundaries and take thoughtful risks with creativity.

Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.

Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.

Join us on our mission. Health. In your hands.

www.opella.com/en/careers

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