Principal Medical Writer – Patient Safety
Company: Parexel
Job ID: R0000042170
Location: Remote (India) / Bengaluru
Category: Medical Sciences
Job Summary
The Principal Medical Writer – Patient Safety is responsible for independently leading complex pharmacovigilance and safety writing activities across global regulatory regions. The role includes aggregate safety reporting, signal detection, risk management planning, scientific leadership, client engagement, quality oversight, mentoring, and strategic contributions to safety and regulatory initiatives.
Key Responsibilities
1. Aggregate Safety Reporting & Documentation
Independently lead the preparation and updating of complex scheduled and unscheduled aggregate safety reports, including:
PSURs
PBRERs
PADERs
DSURs
Addendum to Clinical Overviews (ACOs)
IND Annual Reports (INDARs)
Semi-Annual Safety Reports (SASRs)
Annual Risk-Benefit Evaluation (ARBE) reports
Safety Statements
Health Hazard Evaluations (HHE)
Clinical Overviews (COs)
Other ad-hoc safety documents
Ensure:
Scientific accuracy
Regulatory compliance
Timely submission delivery
Serve as Subject Matter Expert (SME) for safety reports by:
Developing templates
Guiding teams
Creating regulatory and data presentation strategies
Facilitate operational coordination by:
Scheduling and leading meetings
Preparing agendas and minutes
Tracking action items
Ensuring timely follow-up
Conduct detailed reviews for:
Factual accuracy
Internal consistency
Quality compliance across safety reports
Manage final report distribution to:
Partners
Affiliates
Health authorities
2. Safety Analysis & Signal Management
Lead advanced safety signal detection and management activities.
Integrate multiple data sources and analytical approaches to identify emerging safety concerns.
Interpret complex safety trends across product lifecycles.
Lead clinical safety evaluations for complex molecules and sensitive indications.
Collaborate with global safety and study management teams.
Direct literature review strategies and evaluate scientific evidence for safety documents.
Support regulatory positioning through:
High-quality safety reports
Regulatory responses
Strategic safety evaluations
3. Risk Management Plans (RMPs)
Lead development and updates of:
Global RMPs
Company Core-RMPs (CC-RMPs)
Ensure alignment with:
Product safety profiles
Regulatory standards
Strategic objectives
Prepare and review regulatory response documents.
Provide strategic input on:
Risk minimization activities
Benefit-risk communication
Collaborate cross-functionally to ensure scientific and regulatory robustness.
4. Scientific & Strategic Support
Provide strategic scientific expertise across therapeutic areas.
Support:
Safety documentation
Regulatory planning
Risk mitigation strategies
Drive:
Documentation quality improvements
Process optimization
Cross-functional alignment
Represent medical writing in strategic and decision-making forums.
Advise on emerging safety trends and evolving safety profiles.
5. Client Engagement & Collaboration
Lead strategic client engagement for complex safety projects.
Drive discussions and negotiate:
Deliverables
Timelines
Safety strategies
Build strong relationships with:
Clients
Cross-functional teams
Stakeholders
Resolve escalations and enhance client satisfaction through proactive collaboration.
6. Quality Control & Compliance Management
Lead quality oversight for complex safety documentation.
Ensure:
Scientific accuracy
Regulatory compliance
Consistency across global submissions
Drive continuous improvement initiatives by:
Identifying systemic issues
Implementing CAPAs
Establishing KPIs and SLAs
Serve as SME during:
Audits
Inspections
Regulatory reviews
7. Strategic Leadership & Team Coordination
Provide technical leadership and coordinate safety writing teams.
Ensure:
Timely project execution
Effective delegation
Risk management
Regulatory quality
Contribute to:
Business growth
Proposal development
Client engagement
Operational excellence initiatives
8. Training, Mentorship & Team Development
Lead advanced training initiatives in:
Safety writing
Signal detection
Regulatory standards
Mentor and coach team members to support professional development.
Identify skill gaps and development opportunities.
Foster a collaborative and high-performing team environment.
9. Innovation & Technology
Support innovation initiatives and process improvements.
Evaluate and implement advanced technologies to improve:
Safety writing efficiency
Documentation quality
Regulatory alignment
Required Skills
Strong analytical and problem-solving capabilities
Excellent verbal and written scientific communication skills
Strong interpersonal and collaboration abilities
Effective multitasking and prioritization skills
Strong negotiation and stakeholder management expertise
Client-focused and proactive mindset
Cultural awareness and adaptability in global environments
Proficiency in:
Microsoft Office Suite
Web-based applications
Windows operating systems
Medical/scientific documentation tools
Preferred Experience
Prior experience in:
Pharmacovigilance
Drug safety
Medical writing
Related healthcare/scientific fields
Strong understanding of:
Global pharmacovigilance regulations
Medical terminology
Safety-related concepts
Educational Qualifications
Preferred degree in:
Pharmacy
Microbiology
Biochemistry
Biotechnology
Biophysics
Dentistry
Physiotherapy
Life Sciences / Biomedical Sciences
Equivalent education and professional experience may also be considered.
Preferred Advantage:
Clinical or hospital-based exposure.
Core Competencies
Pharmacovigilance expertise
Aggregate safety reporting
Signal detection & risk management
Regulatory compliance
Strategic scientific leadership
Client relationship management
Team mentoring & leadership
Quality systems & audit readiness
Process optimization & innovation
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tamil nadu | Tiruchirappalli | tiruppur | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Australia | North York | Renfrew | Uxbridge | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Netanya | Tel Aviv | Be'Er Sheva | Kfar Saba | Yavne |Remote :
Leinster | Faridabad | Blue Bell | Lenexa | Springville | Victoria | Minnesota | Ireland | Switzerland | Zaragoza | Milwaukee | McFarland | Green Way | Xzagreb | Remote - Middle East | Riga | Remote - Africa | Tulsa | Hammond | Hungary | Melbourne | Medan | Lousiana | Belgium | Remote - South America (Latin Americal) | Regulatory Labeling Manager (NA and LATAM Only) | Bountiful | French | Nairobi | Perth | Slovakia | Bishop | Manipal | Thailand | Castlebar | Texas | Remote - Europe |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
King Abdullah Economic City | Najran | Riyadh | Khulais | Jeddah | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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