Local Medical Safety Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Product Safety

Job Sub Function:

Pharmacovigilance

Job Category:

Scientific/Technology

All Job Posting Locations:

Istanbul, Turkey

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Medical Safety Specialist. This position will be located in Istanbul, Turkey.

Essential Job Duties and Responsibilities

The position is responsible for supporting the compliance of LOC Safety activities of TURGAN cluster by mainly focused on Turkiye, covering medicinal products, with local regulations, company policies, and global standards, including any Product vigilance agreements with third-party partners.

It involves assisting in establishing and maintaining effective Pharmacovigilance and Risk management systems and supporting the oversight of the products within its responsibility.

The role includes contributing to the proactive management of Benefit Risk Management throughout the product life cycle, tailoring actions to local needs. Additionally, it involves aiding in safety reporting requirements as needed by Marketing Authorization Holders (MAH) and study sponsors, as applicable.

Safety Management & Reporting

Oversight and Providing Input

• Support Data-generating Activities: Assist in overseeing data-generating activities to ensure appropriate review and reporting processes are included in project documents for reporting potential Adverse Events (AEs), such as patient support programs, market research surveys, and internet sites, as applicable. Provide support to the Hub for Related Research Activities (RRA) activities, where applicable.
• Vendor Contracts: Ensure, in collaboration with the Hub if applicable, that all vendor contracts have appropriate Pharmacovigilance language incorporated and that these contracts are archived in the global system, as applicable.
• Product Portfolio Oversight: Support the oversight of the full product portfolio and establish links with local management and key stakeholders. Assist in overseeing the safety aspects of clinical studies conducted in the territory, as applicable.

Submission to Regulatory Authority

• Support the coordination of safety requirements delegated by Marketing Authorization Holders (MAH).
• Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners independently and with minimal supervision
• Independently and with minimal supervision, ensure timely submission of aggregate safety reports (e.g. DSUR, PBRERs etc. applicable) to applicable health authorities, in collaboration with local medical safety input (as applicable).
• Independently and with minimal supervision, ensure timely submission of other safety reports (e.g. DHPC, RMP etc. applicable) to applicable health authorities, in collaboration with local medical safety input (as applicable).

Signal Detection

• Assist in implementing a robust local signal detection process if required and ensure the reporting of potential single case signals or clusters of similar events identified during case processing, as applicable.

Aggregate Reporting

• Assist in local review and ensure the submission of Periodic Benefit Risk Evaluaiton Reports (PBRERs), providing due dates to Global Medical Safety (GMS), and promoting synchronization with the Global PSUR schedule, in accordance with national requirements and in collaboration with the local Regulatory Affairs unit.
• Products for Local Opportunity (POLOs): When Global Medical Safety (GMS) does not provide the Aggregate Reports, support the preparation of specific reports (e.g., PBRERs) if not already provided by a third party under a PV agreement, as applicable.

Business Continuity

• Local Business Continuity Plans: Assist in the development and implementation of local business continuity plans (e.g., inspection readiness, Adverse Event reporting coverage) in collaboration with the case management team.
• 24-hour Coverage: Support the establishment of an effective system for 24-hour coverage.
• Day-to-day Pharmacovigilance (PV) Functions: Support to ensure the satisfactory performance of day-to-day Pharmacovigilance (PV) functions and maintain optimal regulatory compliance at the Local Operating Company (LOC) level in collaboration with the case management team.

Risk Management

• Implementation of Risk Management Plans: Support the implementation of Risk Management Plans and Urgent Safety Restrictions, if required.

New Safety Information

• Dissemination of New Safety Information: Assist in taking appropriate measures to ensure that new safety information is available to RA and Health Care Professionals (HCP) in a timely manner, i.e., DHPC, CCDS implementation into local label, USR in collaboration with adequate partners if applicable.

Benefit Risk Management

• Establish product knowledge: Assist in establishing product knowledge with a focus on safety profiles, therapeutic area, and disease pathway knowledge to support the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety Leader or MSO.
• Act as a safety expert: Support safety expert activities in cross-functional team meetings and conduct training on safety-relevant aspects, as appropriate.
• Risk Management Plan status updates: Assist in providing Risk Management Plan status updates.
• Local RMPs/Addendums: Support the preparation of Local RMPs/Addendums, etc. (if performed by LMS)
• Implementation of Risk Management Plans: Participate in the implementation of Risk Management Plans and Urgent Safety Restrictions, if required.
• Benefit-risk and product safety meetings: Participate in meetings with relevant partners to discuss and evaluate topics related to benefit-risk and product safety, as required.
• DHPCs management: Assist in managing DHPCs, submit and track DHPCs to Regulatory Authorities (RAs)/Health Care Professionals (HCPs) (if performed by LMS)
• Support to the HUB: Provide support to the HUB for local RRAs.
• Medical/pharmaceutical assessments: Conduct medical/pharmaceutical assessments of local individual cases when requested in partnership with global teams, if applicable.

Pharmacovigilance and Vigilance Service Provisions

Day-to-day PV functions

• Ensure that day-to-day PV functions and safety activities for nonmedicinal products (i.e., medical devices) are performed satisfactorily, and that full regulatory compliance is maintained at Local Operating Company level.

Collaboration with Marketing Authorization Holders (MAH)

• Collaborate with the local MAH to enable fulfillment of its regulatory responsibilities (including Pharmacovigilance Agreement (PVA’s)) and meet their business objectives.

Training

• Local Operating Company employees: Assist in performing training for Local Operating Company employees covering (pharmacological) safety aspects of products as applicable.
• Watchlist follow-up process: Assist in performing training for Local Operating Company employees covering follow-up process for concepts of special interest (Watchlist) as applicable.
• AE/PQC training: Manage AE/PQC trainings to distributors/vendors and translation of AE/PQC material, where needed. Follow up for completion of global roll-out AE/PQC training in LOC.

Agreements / Contracts containing PV Language

• PSMF Annex B Listings: Assist in providing and/or reviewing quarterly listings for the PSMF Annex B (vendor agreements and commercial agreements) for agreements signed by LOC and ensure accuracy and timelines.
• Contract Review: Support the contract review in collaboration with the Hub if applicable and maintain oversight on the commercial and vendor agreements to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.
• Oversight on Commercial and Vendor Agreements: Support the contract review in collaboration with the Hub if applicable and maintain oversight on the commercial and vendor agreements to ensure safety reporting obligations are defined and integrated into case handling procedures as necessary.

Inspection preparation & support

• PV Inspection Readiness: Assist in ensuring PV audit and inspection readiness on the LOC level.
• Support Inspectors/Auditors: Provide support to assist inspectors/auditors and support document requests in collaboration with the case management team.
• CAPA Content Owner: Act as CAPA Content owner and subject matter expert, own actions as required, depending on the topic.
• Follow-up Actions from Findings: Address follow-up actions from findings.

Local Literature Search

• Local literature screening for ICSRs and potential safety signals (in consultation with local medical safety as needed).

Collaborate & Support

• Assist in collaboration with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups (GMS Support Desk, GMS Physician, QPPV Office, VP PV & Medical Compliance) as appropriate.
• Where applicable, support the CSH to provide safety-related regulatory communication (e.g., response to request for information from local RAs, including the provision of information about the volume of sales or prescription, as appropriate).
• Provide technical and strategic input and participate in projects/ workstreams led by the regional GMS teams.
• Assist in providing timely and accurately PSMF contribution.
• Assist in the implementation and the maintenance of the local “PSMF”.
• Support Country Safety Head / LSO in responding to ad hoc requests (e.g. regulatory authority requests) as required
• Lead or support the coordination and process standardization efforts to cross-country
• collaboration with regards to Local Medical Safety activities
• Lead or support critical project works

Processes & Regulations

Procedural Document Design

• Implementation of Global Pharma PV Documents: Ensure implementation of Global Pharma PV relevant Procedural Documents as applicable and/or assist in writing, validating, and implementing the Local Implementation Documents (LID) for Regional/International PV Standard Operating Procedures/Working Practices and verify adherence. Where appropriate, assist in developing local controlled procedures to cover local aspects of PV/Safety activities
• Document Review and Impact Assessments: Assist in procedural document review from SMEs and Area Leads, depending on the topic. Perform impact assessments and actions as required on the local level, depending on the topic.

Safety Policy/Strategy

• Awareness of Regulatory Changes: Provide support to ensure awareness of changes in regulations that may have an impact on vigilance activities and responsibilities. Evaluateöthe impact on local processes and inform the appropriate global and regional groups (i.e.,öQPPV office and Regional Safety Head) of any changes to local laws and regulations regarding safety.
• Implementation of New Legislation:
  • Support LSO in review of new/revised PV regulations, evaluation of the impact on local processes and notification of appropriate global and regional
  • Ensure the implementation of new legislation with local impact for LMS-owned activities, depending on topics.
• Local Industry Associations Engagement: Focused engagement in local industry associations and drive local policy shaping initiatives based on One J&J Voice.

Safety Reporting & Compliance

• Assist in establishing adequate collaboration with the Local Medical Safety organization to maintain local compliance and local compliance oversight on case processing, reconciliation, and submission to RA.
• Support to provide insights into metrics to local management and LMS, lead actions as needed.
• Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable
• Collaborate with local Commercial Quality organization to ensure oversight on local CAPA with potential impact on PV.
• Support maintaining oversight of CAPAs that could impact local processes.

Perform related duties as assigned by supervisor.

Assist in maintaining compliance with all company policies and procedures.

Minimum Qualification

• Bachelor’s degree in medicine or pharmacy is required.
• Proven ability to prioritize workflow activities and manage multiple critical issues.
• Awareness of and familiarity with industry principles of product vigilance, drug development and pharmacology.
• Basic knowledge of Global, Regional and Local Procedural Documents as applicable.
• Computer literate with knowledge of relevant IT safety systems.
• Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.
• Ability to establish and maintain open relationships within the organization and with authorities.
• Ability to prioritize and work to strict timelines daily
• Demonstrable knowledge of all local requirements and of global aspects of product safety.
• Fluency in the national language(s) and the English language is required.

Other Requirements

• Proven expertise and experience in pharmaceutical regulations and R&D processes is preferred.
• By preference a minimum of 1+ years pharmaceutical industry experience in a product vigilance responsibility role

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